Conclusions: Patients over 35 years were preliminarily diagnosed as advanced FIGO stage and they were more likely to have deep stromal invasion, LVSI, LN metastases, parametrial and surgical margin involvement. Regarding to young patients, cervical adenocarcinoma increased the risk of LN metastases and positive postoperative pathological risk factors could apparently worsen the prognosis. Histological type and LN metastases were independent prognostic factors for young patients in southwestern China. We re-emphasize the importance of health education and regular smear screening for elder women, and more attention should be paid to young patients with adenocarcinoma or LN metastases.
Poster #005 Factors Affecting Recurrence After Conization in Patients With Uterine Cervical Lesions
Hidenori Sasa1, Kigna Sei1, Ayako Suzuki1, Hideyuki Shimazaki1, and Kenichi Furuya1. 1National Defense Medical College
Objective: To retrospectively determine recurrence after conization, in patients with uterine lesions during routine cervical cytology at our hospital.
Methods: Between 2009 and 2015, 239 patients (mean age: 41.8 years) with uterine cervical lesions underwent conization at our hospital. Cervical cytology was performed every 3 months after conizaton; colposcopy and biopsy were used for further examination. The patients who relapsed after conization were analyzed retrospectively.
Results: Of the 239 patients who underwent conization during the study period, 11 patients (4.6%) relapsed. The mean duration of recurrence was 20.8 (range: 3–75) months, and six patients relapsed within a year after conization. Histology of the first conization revealed CIN3 in 10, microinvasive carcinoma in one, and positive surgical margin in eight cases, respectively. Two cases were diagnosed based on the detection of abnormal cytology alone, and the remaining nine cases were diagnosed based on cytology and histology. Six patients underwent re-conizaton and five received hysterectomy. The final diagnosis revealed CIN3 in six, no lesions in two and invasive carcinoma in three cases, respectively. The recurrence rate was significantly higher in cases with positive surgical margin of the specimen than that in cases with negative margin, i.e., 8/92 vs. 3/147 (8.7% vs. 2.0%), respectively (p = 0.02).
Conclusions: Recurrence after conization might be affected by positive surgical margin of the specimen and the duration of recurrence. The human papillomavirus test may be useful in predicting recurrence after conization.
Poster #006 Clinical Analysis of Cervical Cancer in High-Risk HPV Negative
Hu Yan1 and Yang Hongying1. 1Yunnan Tumor Hospital
Objective: To investigate the clinical characteristics of high-risk HPV negative cervical cancer.
Methods: The clinical datas of 911 cases of cervical cancer in Yunnan cancer hospital from December 2013 to January 2016 were analyzed retrospectively. Application of SPSS17.0 statistical software was used for data analysis.
Results: In cervical cancer patients, HR-HPV positive in 813 cases (89.24%, 813/911), HR-HPV negative in 98 cases (10.76%, 98/911) accounted for 10.76%, p=0.001, the difference between the two was statistically significant. Age stratification, nationality, clinical stage, HPV positive group and negative comparison were not statistically significant between the two constituent ratios. Pathological types:To compare HR-HPV positive squamous cell carcinoma of the cervix, adenocarcinoma, neuroendocrine carcinoma and HR-HPV negative group, we find the difference between the two was statistically significant.
Conclusions: The negative results of HPV detection exists in cervical cancer. The result of HPV negative is related to its pathological type.
Poster #007 Positive CK7 Expression Associated With Progression of Cervical Squamous Low-Grade Intraepithelial Lesions
Yiying Wang1, Yan Wang1, Hao Chen1, and Wenxin Zheng1. 1UT Southwestern Medical Center
Objective: This study is to further address whether the CK7 positive LSILs carry higher risk for developing HSIL.
Methods: IHC staining using antibody against CK7 was performed on a total of 120 cervical biopsy specimens with confirmed diagnosis of LSIL. LSILs were categorized into 2 group: CK7 positive LSIL and CK7 negative LSIL. CK7 positive lesion is defined as diffuse cytoplasmic staining of > 5 contiguous cells (Figure1). Follow-up period ranged from 6 to 48 months, with an average of 32 months. Follow-up methods can be either Pap smear or cervical biopsy. Follow-up ended when HSILs were identified by either histology or cytology. Follow-up lesions were classified into 2 groups: non-HSILs (including LSIL or less conditions) and HSILs (CIN2 or higher) confirmed by p16 IHC staining. Ectocervical squamous epithelia and benign SCJ endocervical glands were used as negative and positive control for CK7 IHC staining. The results were analyzed using Chi-square test.
Results: All control sections worked properly with negative stains in ectocervical squamous cells and positive in either normal SCJ cells and/or endocervical glands. Among 120 LSILs, 36 cases (30%) were CK7+, while 84 cases (70%) were CK7-. Among CK7+ LSILs, 56% developed into HSILs during follow-up period. This was significantly higher than the CK7- lesions, of which only about 6% cases developed into CIN2+ disease (p < 0.0001, Chi-square test) in a 4-year follow-up period. The detailed results are summarized in Table 1.
Conclusions: CK7 positive LSILs carry significantly higher risk for developing HSIL than CK7 negative LSILs. CK7 can be a good prognostic biomarker for identifying high risk LSIL, hence guiding the clinical management of patient with LSILs.
Poster #008 High Risk HPV Test in Detection of Cervical Cancer and Precancerous Lesion
Li Geng, Xuefei Ge1, Yanli Guo1, Ruiyi Zhang1, and Ke You1. 1Peking UniversityThird Hospital
Objective: To investigate the role of high risk HPV (HR-HPV) test in the detection of CIN2+ lesions.
Methods: A total of 2626 women who were screened at Peking University Third Hospital from September 2016 to May 2017 were recruited. The liquid based cytology (Hologic Thinprep), high-risk HPV test (Roche Cobass4800), colposcopy and cervical biopsy were applied in all women.
Results: The age of all women ranged from 18 to 85 years old, the average age was 38.02 years old. The results of pathological diagnosis showed that 60.2% (1580/2626) was ≤CIN1, 26.6% (699/2626) was CIN2, 10.3% (270/2626) was CIN3, and 2.9% (77/2626) was cervical cancer. The detection rate of CIN2+ was 90.2% by cytology and 96.8% by HR-HPV test. The detection rate of CIN2+ was 99.5% by cotesting, which was significantly higher than the two former methods (p=0.000, p=0.000). The HPV infection rate in CIN2+ group was 96.8% (1013/1046), the rate of HPV16 single infection and HPV16 multiple infections were 25.2% (255/1013) and 20.0% (203/1013), respectively. The HPV infection rate in CIN3+ group was 97.1% (337/347), the rate of HPV16 single infection and HPV16 multiple infections were 40.7% (137/337) and 64.2% (88/337). Logistic regression analysis showed that compared with patients with HPV negative women, the risk of CIN2+ and CIN3+ in HPV positive women was 5.337 (p=0.000, 95%CI:3.673-7.753) and 4.283 (p=0.000, 95%CI:2.254-8.141), respectively. When HPV positive women were further classified, logistic regression analysis showed that women who has HPV16 type single infection or multiple infections were checked out the highest risk of CIN2 + [OR value was 11.093 (95% CI: 7.332 16.784), 10.356 (95% CI: 6.780 15.817)], also the highest risk of CIN3 + [OR value was 12.530 (95% CI: 6.451 24.338), 8.904 (95% CI: 4.526 17.517)].
Conclusions: HR-HPV test is superior to cytology in detection of CIN2+. And cotesting can improve the detection of CIN2+ and reduce missed diagnosis. HR-HPV infection, especially HPV 16 positive, is related with CIN2+ lesions.
Poster #009 Efficacy of a Coriolus Versicolor-Based Vaginal Gel to Repair Cervical Mucosa With HPV Lesions. Interim Analysis Results
Luís Serrano1, Andrés Carlos López2, Silvia González1, Santiago Palacios3, Damián Dexeus4, Cristina Centeno5, Pluvio Coronado6, Jesús de la Fuente7, José Antonio López Fernández8, Cristina Vanrell9, and Javier Cortes10. 1Gabinete Médico Velázquez, 2Hospital Quironsalud, 3Instituto Palacios, Salud y Medicina de la Mujeri, 4Women's Health Institute, 5Clínica DIATROS, 6Hospital Clínico San Carlos, 7Hospital Universitario Infanta Leonor, 8Hospital General Universitario, 9Hospital de la Santa Creu i Sant Pau, 10Private Practice
Objective: To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- to repair cervical mucosa in women with HPV-related pap alterations and consistent colposcopy image.
Methods: A randomized, open-label, parallel-group, controlled clinical trial. Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US or LSIL or AG-US and concordant colposcopy image, randomized into 3 groups: A) Papilocare® 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare® 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment. Preliminary analysis of percentage of patients with normal pap and concordant colposcopy image at 3 months in both total and high-risk genotype virus population are presented. Pap smear evaluation is being centrally-conducted in IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this analysis.
Results: Data from 50 patients at 3 months are available. 70% of patients using Papilocare® (n=30) had negative pap and colposcopy vs. 40% in control group (n=20) (p=0.045; Fisher test). High risk genotypes virus was detected in 37 patients. At 3 months, normal pap and concordant colposcopy image was observed in 68% of patients using Papilocare® (n=22) vs 33.3% of patients in control group (n=15) (p=0.049; Fisher test).
Conclusions: In these preliminary results, Papilocare® shows a significant difference in repairing HPV-cervical lesions at 3 months versus control in both total and high-risk genotype virus populations; these findings need to be confirmed upon study completion.
Poster #010 Efficacy of a Coriolus Versicolor-Based Vaginal Gel to Clear HPV. Interim Analysis Results
Luís Serrano3, Santiago Palacios1, Andrés Carlos López2, Silvia González3, Damián Dexeus4, Cristina Centeno5, Pluvio Coronado6, Jesús de la Fuente7, José Antonio López Fernández8, Cristina Vanrell9, and Javier Cortes10. 1Instituto Palacios, Salud y Medicina de la Mujer, 2Hospital Quironsalud, 3Gabinete Médico Velázquez, 4Women´s Health Institute, 5Clínica DIATROS, 6Hospital Clínico San Carlos, 7Hospital Universitario Infanta Leonor, 8Hospital General Universitario, 9Hospital de la Santa Creu i Sant Pau, 10Private Practice
Objective: To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- to clear HPV at 6 months.
Methods: A randomized, open-label, parallel-group, controlled clinical trial. Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US or LSIL or AG-US and concordant colposcopy image, randomized into 3 groups: A) Papilocare® 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare® 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment. Preliminary analysis of percentage of patients with HPV clearance at 6 months in both total and high-risk genotype virus population are presented. HPV genomic evaluation has been centrally-conducted in IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this analysis.
Results: Data about HPV clearance from 26 patients are available. HPV clearance was observed in 56% of patients using Papilocare® (n=16) vs 30% in control group (n=10) (p=0.247; Fisher test). High risk genotypes viruses were detected in 18 patients. At 6 months, 50% of patients in Papilocare® group (n=12) showed HPV clearance vs 17% (n=6) in control group (p=0.315; Fisher test).
Conclusions: In these preliminary results, Papilocare® shows a positive trend in HPV clearance at 6 months, especially in high risk genotype virus population; these findings need to be confirmed upon study completion.
Poster #011 Use of a Coriolus Versicolor-Based Vaginal Gel in Patients With Precancerous HPV Lesions. Interim Analysis Results
Luís Serrano3, Santiago Palacios1, Andrés Carlos López2, Silvia González3, Damián Dexeus4, Cristina Centeno5, Pluvio Coronado6, Jesús de la Fuente7, José Antonio López Fernández8, Cristina Vanrell9, and Javier Cortes10. 1Instituto Palacios, Salud y Medicina de la Mujer, 2Hospital Quironsalud, 3Gabinete Médico Velázquez, 4Women's Health Institute, 5Clínica DIATROS, 6Hospital Clínico San Carlos, 7Hospital Universitario Infanta Leonor, 8Hospital General Universitario, 9Hospital de la Santa Creu i Sant Pau, 10Private Practice
Objective: To evaluate the efficacy of PapilocareR -a Coriolus versicolor-based vaginal gel- to repair cervical mucosa in women with HPV-related cytology alterations and consistent colposcopy image.
Methods: A randomized, open-label, parallel-group, controlled clinical trial. Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US, LSIL or AG-US and concordant colposcopy image, randomized into 3 groups: A) PapilocareR 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) PapilocareR 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment as usual practice. Interim analysis of secondary endpoints - changes in epithelialization of the cervix evaluated by standard colposcopy and in perceived stress evaluated by PSS14 - are presented. PapilocareR arms (A+B) were combined for this evaluation.
Results: Data from 47 patients at 3 months and 29 patients at 6 months are available. 20.7% and 47.5% of patients in PapilocareR group improved the cervix epithelialization at month 3 and 6 respectively vs 22.2% and 16.7% in control group (p=ns). A trend to stress reduction vs basal was observed in the treatment group at month 3 (−0.9 points) and was significant at month 6 (−2.9; p=0.045, Student´s t-test). Patients in control group showed a trend to stress increase at month 3 and 6 (+0.5 and +4.7; p=ns). There were not significant differences between treatment groups.
Conclusions: In these interim analysis results, PapilocareR shows a positive trend in cervix epithelialization and a significant stress reduction; these findings need to be confirmed upon study completion.
Poster #012 Performance of Methylated PAX1 Genes for Monitoring of the Response of Neoadjuvant Chemotherapy in Cervical Cancer
Mingzhu Li1 and Lihui Wei1. 1Peking University People's Hospital
Objective: To explore the value of Methylated PAX1 genes in predicting or monitoring the effect of neoadjuvant chemotherapy(NACT).
Methods: Sixteen Ib-IIb primary cervical cancer patients were treated with neoadjuvant chemotherapy. Tissues from Cervical biopsy(before NACT) and radical hysterectomy(after NACT) were collected from February 2009 to October 2015 at the Peking University People’s Hospital (Beijing, China). The methylation levels of the PAX1 gene was determined using qPCR. The different M-index values of the PAX1 gene before and after NACT were evaluated.
Results: The methylation level of the PAX1 was higher in SCC tumor tissues than in NCMT parts (p<0.001).The patients with stage II tumors had significantly higher PAX1m levels than those with stage I tumors. The methylation level of PAX1 decreased significantly after NACT treatment (p<0.05). Patients with CR or PR showed significantly lower methylation for PAX1 after NACT than the patients with stable or no change response to chemotherapy (p=0.026–0.093), the change of methylation level was positively correlated with the change of tumor size.
Conclusions: The detection of methylated PAX1 genes may predict and monitor the response to neoadjuvant chemotherapy, especially those chemotherapy resistant and intractable cervical cancer.
Poster #013 Provider Perceptions Towards Cervical Cancer Prevention: Preliminary Results From a Survey in El Salvador
Karla Alfaro1, Mauricio Maza1, Montserrat Soler1, Gabriel Conzuelo1, Rachel Masch1, and Miriam Cremer2. 1Basic Health International, 2Cleveland Clinic
Objective: To learn about clinician’s perceptions and screening practices regarding cervical cancer, and uncover factors that can influence the adoption of HPV-based screening methods in different practice settings.
Methods: A survey was administered to 38 clinicians (expected final sample = 140) who provide cervical cancer screening services in the catchment area of a primary HPV screening program sponsored by the Ministry of Health in El Salvador. Providers answered questions regarding knowledge of cervical cancer, HPV, and attitudes toward screening methods and practices.
Results: Participants were gynecologists, general providers, and nurses with an average of 5.6 (SD = 6.2) years of practice. The majority knew that cervical cancer is preventable and that precancerous lesions are asymptomatic (97.4% and 100%, respectively), but a quarter (26.3%) erroneously believed that cervical cancer was not a main cause of death in El Salvador, 21.6% did not believe HPV can be transmitted through genital contact, and 89.5% did not believe that most sexually active women will have HPV during their lives. Only 13.5% correctly believed that follow-up is easier with HPV than cytology. Almost 66% reported feeling uncomfortable using HPV self-sampling with patients, yet 80% felt they had enough knowledge about HPV self-sampling to advice patients.
Conclusions: Providers who are participating in a national screening program using HPV testing for cervical pre-cancer have significant gaps in knowledge about HPV acquisition, testing and follow-up. As this successful MOH program scales up it will be important to improve provider training and close these knowledge gaps.
Poster #014 Analyzed the Clinical Characteristic of Cervical Cancer During Pregnancy From 80 Cases Reports
Yun Zhao1, Mingzhu Li1, and Lihui Wei1. 1Peking University People's Hospital
Objective: From analyzing the characteristics of 80 cases of cervical cancer during pregnancy to summarize the pregnancy outcomes.
Methods: There are 80 cases of cervical cancer diagnosed during pregnancy from 18 top-level hospitals all over the China from Jan 2009 to Jul 2017, Collecting their clinical information during pregnancy and postpartum, the study summarized the characteristic and pregnancy outcomes of cervical cancer during pregnancy.
Results: In these hospitals during the same time, the total number of delivery is 293855 cases. The total number of cervical cancer is 28723, the morbidity of cervical cancer during pregnancy is 0.216%. The mean age of these patients is 33 years old. For the cervical cancer cases during pregnancy, the rates of cervical cancer diagnosed during early, middle, late pregnancy is 37.5% (30/80), 27.5% (22/80), 35% (28/80) respectively. Among them, stage IA1, IB1, IB2, IIA, IIB, IIIB5% (4/80), 30% (24/80), 26.25% (21/80), 16.25% (13/80), 11.25% (9/80), 6.25% (5/80) respectively.The histology pathology is as below, squamous cases is 66 cases, then glandula cases is 10 cases. There are 85% (68/80) came for the clinical complaints. Among them, abnormal bleeding is the main reason, accounts for 92.6%(63/68; there are 8.75% (7/80) came for clinical because of abnormal screening results 6.25% (5/80). 65% (52/80) patients never screened in recent 5 years. For the patients diagnosed during early stage, 96.7% (29/30) terminate pregnancy. 27.3% of the pregnancies were selected to retain the fetus (6/22) and the remaining 16 were selected to terminate the pregnancy. Late pregnancies were 82.1% (23/28 cases), with an average of 33 weeks. 17.6% (5/28 cases) termination of pregnancy.
Conclusions: Conclusion: 1. When cervical cancer is found in pregnancy, it is mainly in the middle and late stage of pregnancy; 2. Patients with cervical cancer should be admitted with clinical bleeding symptoms. 3. Most patients with cervical cancer have not been screened in 5 years, 4. In China, most of patients with cervical cancer diagnosed during early pregnancy will terminate the pregnancy. Late trimesters are more likely to terminate the pregnancy after the lung has matured.
Poster #015 The Study of Folate Receptor-Mediated Staining Solution (FRD™) Used for Cervical Cancer Screening
Yun Zhao1. 1Peking University People's Hospital
Objective: To evaluate the significance of the Folate Receptor-Mediated Staining Solution (FRD™) when used for cervical cancer detection, by comparing it with the results of the thin-prep cytology test and high risk HPV test and using pathological results as the gold standard.
Methods: The FRD™ is a special staining method for rapid visualization of CIN2+. Results are determined by the color changes of the stain. The FRD™ was applied on the cervix and the cervical canal separately, and the color change was observed. Brown or green indicates a negative result, and blue, bluish-black, or black indicates a positive result. The women included in this study were returning for evaluation by colposcopy based on an abnormal cervical cytology result, a postive HPV result, or showed symptoms of increased leucorrhea discharge or postcoital bleeding. The FRD™ test was performed before colposcopy. A biopsy, and histopathological examination were conducted as needed.
Patients with a positive FRD™ result of the cervical canal, colposcopy assessment type is II-III, or the result of cytology was AGC, were required to complete an ECC as well.
Results: 1,504 women with histological findings were included in the study. CIN2+ was found in 561 patients (37.3%) including 50 patients with cervical invasive cancer (3.3%). CIN1 and negative cases accounted for 29.3% and 33.4%, respectively. Pap results included NILM in 394 women (26.2%), ASC-US in 476 women (31.6%), LSIL in 334 women (22.2%), ASC-H in 96 women (6.4%), AGC in 10 women (0.7%), and HSIL in 194 women (12.9%). The HPV positive rate was 89.0% (1338/1504). A positive FRD™ test was determined in 54.1% of the women (813/1504). The sensitivity to detect CIN2+ lesions for TCT, HPV, and FRD™ was 80.4%, 95.5%, and 77.7%, respectively. The specificity was 30.1%, 15.0%, and 60.0% respectively.
Conclusions: From this study we found that the results of the FRD™ and the cytology examination are similar when detecting CIN 2+. The FRD™ can indicate the tumor tendency of epithelial tissue in direct proportional to the organization of the morphological changes. Furthermore, the more serious the nature of lesion and the higher the level, then the more accurate the results of the FRD™ were. Also, this study shows that the FRD™ results can accurately reveal the level of the epithelial tissue lesions.
Finally, in this study, we compared the sensitivity and specificity of the FRD™ to the cytology examination, and found that the FRD™ can meet the demands of clinical requirements needed for the detection of abnormal cervical lesions (CIN 2+). Furthermore, the FRD™ is an easy and very inexpensive method that can be used in less-developed countries.
Poster #016 The Evaluation of the Folate Receptor-Mediated Staining Solution in Detecting High Grade Cervical Lesions
Zhiyin Pan2 and Mena Farag1. 1GY Highland Biotech LLC, 2Foshan First People's Hospital
Objective: This study is designed to analyze the clinical value of the Folate Receptor-Mediated Staining Solution (FRD™), for detecting cervical lesions compared by thinprep cytology test (TCT) and high-risk human papillomavirus (HR-HPV).
Methods: 632 women (30–65 years) who perform gynecologic examination were recruited for cervical cancer screening from January 2015 to December 2016. Meanwhile, a biopsy was performed to confirm any suspicious lesions among the patients with FRD™ positive, TCT abnormal, or HPV positive results. Abnormal TCT test accounted for atypical squamous cells, or low-grade/high-grade squamous intraepithelial lesions. Finally the diagnostic significances of the FRD™ were compared with the TCT and HPV test.
Results: 186 of 632 patients were detected by biopsy and 40 of them are diagnosed with CIN2+. The sensitivity and specificity of the FRD™ were 77.50% and 94.52% in detecting cervical lesions, respectively. Meanwhile, the positive predictive value (PPV), negative predictive value (NPV), and kappa value were 79.49%, 93.88%, and 0.73, respectively. On the other hand, the sensitivity and specificity of TCT in screening cervical lesions were 90.00% and 73.29% respectively. PPV, NPV and kappa value for TCT were 48.00%, 96.40% and 0.48 respectively. Likewise, these index value of HPV were 87.50%, 70.55%, 44.87%, 95.87% and 0.43, respectively. We also investigated the consistency index of combination screening (TCT+HPV) and the sensitivity, specificity and coincidence rate were 97.50%, 60.96%, and 68.82%.
Conclusions: The ability of the FRD™, TCT, and HPV test to screen for cervical lesions were compared. We found that the sensitivity of FRD™ (77.50%) was lower than TCT (90.00%) and HPV (87.50%), however, the specificity and coincidence of the FRD™ (94.52% and 90.86%) was higher compared with TCT (73.29% and 76.88%) and HPV (70.55% and 74.19%). As reported in previous studies, the combination test of TCT and HPV showed a favorable sensitivity in screening cervical lesions. In conclusion, the FRD™ staining method is a rapid, simple, and accurate detecting method and is capable of screening of cervical precancerous lesions, and can be used for early detection of cervical cancer.
Poster #017 Clinical Evaluation of Cold Knife Conization for Diagnosis and Treatment to Cervical Cancer Patients
Chao Zhao1, Shiyan Wang1, Shuo Liu1, Chong Meng1, Jianliu Wang1, and Lihui Wei1. 1Peking University People's Hospital
Objective: To evaluate the clinical value of conization in the diagnosis and treatment of cervical cancer patients?
Methods: 125 patients diagnosed with cervical cancer after cold knife conization in our hospital between 2008.1 and 2016.9 were reviewed? The pathological profiles of conization specimens and treatment options were analyzed?
Results: Among them, there were 116 squamous cell carcinomas, 7 adenocacinomas, 1 neuroendocrine carcinoma and 1 adenoid basal carcinoma. In 116 squamous cell carcinomas, there were stage Ia1(n=77), stage Ia2 (n=5)and stage Ib1(n=34)? In 7 adenocacinomas, there were stage Ia1 (n=3), stage Ia2 (n=2) and stage Ib1(n=2)? Among 41 patients with stage Ia1 squamous cell carcinomas undergoing further surgery,14 (34.1?) had residual diseases, including CIN II(n=9), CIN3 (n=4) and squamous cell carcinoma (n=1)? No recurrence was found in 36 cases without further surgical intervention. All cases of stages Ia2 and Ib1 underwent repeat surgery?
Conclusions: Cold knife conization plays a very important role in the diagnosis and treatment of cervical cancer patients?Further treatment options should be selected individually and comprehensively based on such factors as patient’s age, degrees of dysplasia, surgical margin status, fertility requirements and so on?
Poster #018 A Low-Cost Solution to Expand the WHO's "Screen and Treat" Initiative to Address Cervical Cancer in Developing Nations
Ria Shroff1, Nika Shroff2, Yatin Thakur3, Vidya Thakur4, Richard Penketh5, and Benedikt Tas6. 1Rensselaer Polytechnic Institute, 2AVHS, 3Basildon University Hospital, 4Brookfield Hospital, 5University Hospital, 6ZNA Stuivenberg
Objective: To describe the design, development, and initial multicenter evaluation of a novel device to help expand the WHO recommended single-visit “screen and treat” approach to address cervical cancer deaths in low and middle-income countries (LMICs).
Methods: We have developed a novel scalable solution to reduce patient discomfort and be usable by non-experts to perform VIA screening. This unibody design, inspired by the transvaginal ultrasound probe, is manufacturable using material from reclaimed plastic bottles and provides an ultra-low-cost replacement to a traditional speculum. It attaches to a smartphone to instantly provide built-in lighting, high-resolution imaging, and multimedia data capabilities. The open architecture of the smartphone platform and its growing ubiquity in LMICs creates intriguing possibilities - from teletraining/diagnosis to real-time teleguidance via private chat platforms. After obtaining informed patient consent, it has been evaluated in 182 patients undergoing cervical and vaginal examinations to assess patient discomfort, lighting adequacy, and visualization compared to the traditional speculum.
Results: The proposed probe design appears superior to a traditional speculum for patient-reported discomfort with mean (range) pain scores on VAS of 3.4 (0.0-8.8) vs. 6.1 (3.2-10.0), and lighting adequacy score of 4.9 (4.0-5.0) vs. 2.9 (2.3-5.0) on a 5-pt scale; while it was comparable in terms of visualization with scores of 4.5 (3.0-5.0) vs. 4.7 (3.0-5.0) on 5-pt scale).
Conclusions: This novel solution has the potential to help expand “screen and treat” efforts in LMICs, by improving patient comfort and usability, and may enable non-expert healthcare workers to participate.
Poster #019 Peniscopies’ Analysis and its Relation With the Human Papillomavirus Infection (HPV)
Alessandra Godoy1, Isnard Elman Litvin1, Mariana Vetturazzi de Souza1, and Francisco Bertelli Ramos1. 1UCS
Objective: The Human Papillomavirus (HPV) is a DNA virus related to cervical and penis cancer. The aim of this study was establish the relation between results of peniscopies and the infection by HPV in men.
Methods: A retrospective study involving consecutive patients, partners of women with HPV injury or suspected HPV injury, who underwent peniscopy in referral service, was conducted in 2016. The analyzed topics were: age, quantity and location of the lesions visualized during the peniscopy, biopsy and Polymerase Chain Reaction (PCR) for HPV-DNA.
Results: One hundred peniscopies were analyzed. About 80% of the patients declare that they don’t have macroscopic lesions before exam. Fifty-four exams presented abnormal. Multiple lesions were found in 38 (70%) of the abnormal exams. The main location affected was the penis’ body (70%). The biopsies showed: 38 low-grade lesions (70%), 9 inflammatory lesions (16,5%), 4 coexistence of low-grade and inflammatory lesions (7,5%), 1 high-grade lesion (2%), 1 inconclusive lesions (2%) and 1 (2%) biopsy not realized. Only 17 (31%) patients with abnormal peniscopy had the PCR done, 10 were positive. Within the patients with normal peniscopy, 16 (35%) had the PCR done, 9 (56%) were positive.
Conclusions: Most patients have HPV lesions and did not recognize, which are responsible for viral dissemination. Multiple lesions caused by HPV are more frequent. Normal peniscopy does not mean absence of viral infection. This information suggests that every man whose partner has an intraepithelial lesion should be examined.
Poster #020 HPV Genotyping Results of a Large Cohort of Cervical Cancer Patients From a Unique Center in China
Xiang Tao, Li Wang1, and Xianrong Zhou1. 1Obstetrics and Gynecology of Fudan University
Objective: To understand the hrHPVs distribution of cervical cancer in China will help determine a reasonable range of HPV genotypes for screening purpose. This study was to investigate the prevalence and genotypes of HPV in a large cohort of cervical cancer samples, which will shed some light on HPV–based cervical cancer screening in China.
Methods: Consecutive received 1000 cases of surgical specimens of cervical cancer at Obstetrics and Gynecology Hospital of Fudan University were enrolled from August 1, 2015 to April 30, 2017. Totally 951 cases with enough tumor tissues for further testing. DNA samples were extracted from paraffin-embedded tissues using Qiagen FFPE DNA kit (Qiagen, Germany). 21-genotyping was performed by BMRT assay-a real time PCR based kit (BioPerfectus Tech Company, Taizhou, China). The HPV genotypes included 13 hrHPV, 4 potential hrHPV and 4 low risk HPV.
Results: The most common HPV genotypes found in 951 cervical cancer samples were HPV16/18 (83.91%, 15.35%), followed by HPV58, 59, 56, 52 and so on. No lrHPV was found in cervical cancer without simultaneously infected by hrHPV. In the rest of 79 HPV16/18 negative cases, 29 were HPV negative cases. HPV58, 31, 26 was positive in 15, 7, 4 cases, respectively. HPV26/68/73, belonging to potential hrHPV, were positive independently from hrHPV. HPV16 accounted for most of squamous cell carcinoma (SCC) (64.16%), adenocarcinoma (ADC) (44.92%) and adenosquamous cell carcinoma (ADSC) (46.67%), while HPV18 mostly concentrated in ADC (23.1%) and ADSC (23.8%). In HPV16/18 negative patients, there were 12 cases of HPV58, 7 cases of HPV31 and 9 cases of HPV negative in 52 cases of SCC; among 22 cases of ADC, 18 cases in HPV negative, and 1 cases in each of HPV26/56/58/66. The correlation coefficients of HPV16, 18 and other 12 high-risk types before and after operation were 0.61, 0.74 and 0.62 (P <0.01).
Conclusions: HPV16 and 18 genotypes infection accounted for 91.7% in cervical cancer, suggesting that hrHPV genotyping detection to distinguish HPV16/18 is of great significance for cervical cancer screening. The potential hrHPV can be present in cervical cancer alone, especially the high positive rate of HPV26, indicating that detection of middle risk HPV can help reduce missed diagnosis. Low-risk HPV is not associated with cervical cancer.
Poster #021 Inter-Observer Agreement Levels in Colposcopic Assessments and Standardization With DSI
Emmanouil Papagiannakis3, Simon Leeson1, Srividhya Budithi1, and Nassera Banu2. 1Ysbyty Gwynedd, 2Ysbyty Glan Clwyd, 3DYSIS Medical
Objective: Feasibility study on inter-observer agreement in colposcopic assessments and standardization by dynamic spectral imaging (DSI) and mapping.
Methods: Three BSCCP-accredited colposcopists reviewed a 3-minute high-resolution image set of acetowhitening and the corresponding DSI map from 57 colposcopy cases. Reviewers (knowing the patients’ age and cytology but blinded to histology), described morphology and provided colposcopic impression, DSI map interpretation and biopsy decisions. Agreement levels are assessed by pair-wise kappas.
Results: All reviewers agreed on impression on six, and all disagreed on 25 cases. The overall accuracy in classifying all cases (between Normal, Low or High-Grade) was 40%, 35%, 44% for the three reviewers, and 78%, 26%, 74% for the cervical intraepithelial neoplasia grade two or worse cases (sensitivity). Pair-wise agreements for impression (Normal/Low-Grade vs High-Grade) were mostly poor, also when cases were stratified according to histology (kappas: 0.080-0.277). Agreement on morphology was poor, when classifying mosaicism as not-present, fine or coarse the agreement was 77%, 44%, 46% (weighted kappas 0.204, 0.120, 0.204). Notably the highest agreement levels for impression vs morphology were in different reviewer pairs, suggesting that individual judgements vary in their aspects. When interpreting the acetowhite changes based on DSI as suggestive of a Normal, Low or High-Grade cervix, opinions converged: 80%, 91%, 89% (kappas: 0.507, 0.727, 0.746).
Conclusions: This preliminary review involving three colposcopists suggests that inter-observer agreement on assessments is poor, yet impression remains an important risk factor considered in assessments and decisions at colposcopy. The DSI map introduces standardization that can lead to improved accuracy.
Poster #022 A Proposal of New Diagnostic Device for Cervical Precursor Lesion; a Clinical Application of Photoacoustic Imaging
Kiguna Sei1, Shinpei Okawa1, Hidenori Sasa1, Kazuhiro Hirota2, Kaku Irisawa2, Takatsugu Wada2, Kenichi Furuya1, and Miya Ishihara1. 1National Defense Medical College, 2FUJIFILM Corporation
Objective: The early diagnosis of cervical precursor lesion by Pap test and colposcopy is important in prevention of cancer. However, the accuracy of colposcopy have been questioned. We applied a photoacoustic (PA) imaging technique to detect severe lesions≥cervical intraepithelial neoplasia 2.
Methods: PA microvessel images with B-mode images were acquired by our system. The participants were outpatients of our colposcopy clinic. Transvaginal PA imaging to assess the stromal angiogenesis, Pap test, and colposcopy-directed biopsy and surgical treatment were performed. The accuracy and reliability of the PA imaging were assessed by three methods; (i) search for dense PA signals referred to as “hot spot” in the case of severe cytology, (ii) histological assessment of the hot spots in the case of surgical treatments, (iii) evaluation of the rate of severe lesion detected by the hot spots.
Results: Total participants were 114 and 23 underwent surgical treatment. The agreement rate of cytology and histology was 66.2%. The results of assessment of PA image were; (i) the hot spots were observed in 81 patients out of 83, (ii) the microvessel density significantly related to the hot spots (p<0.0001), (iii) the positive and negative predictive values to detect severe lesion by PA images were 84.5 % and 82.1 %, respectively.
Conclusions: Our results indicated the possibility of the PA imaging technique to detect severe lesion, and demonstrated that the PA imaging technique can be a new device to add useful information to ultrasound diagnosis.
Poster #023 Accuracy of Colposcopic Clinical Impression Among Obstetrics and Gynecology Residents
Mahta Rouhani1, Michael Pirics1, Lisa Kimbell1, and Konrad Harms1. 1Houston Methodist Hospital
Objective: Despite the decrease in invasive cervical cancer in recent years, cervical dysplasia remains prevalent as a major health concern for women. The subjective nature of colposcopy requires an experienced physician. The goal of this study is to examine the accuracy of resident colposcopic clinical diagnosis at The Houston Methodist obstetrics and gynecology program.
Methods: This is a retrospective analysis of patients who underwent colposcopy at The Raymond H. Kaufman Dysplasia Clinic at Houston Methodist Hospital in Houston, Texas. We compared the percent accuracy between each year of the R1, R2, R3, and R4 resident levels. Comparisons were performed using Chi-squared tests with p-values <0.05 considered statistically significant. Samples were in agreement if the resident correctly predicted the histology on a four step scale: negative, low-grade lesion, high-grade lesion, invasive cancer.
Results: Resident clinical diagnosis agreed with histology in 127 of 255 (49.0%) colposcopic examinations. R1, R2, R3, and R4 residents were correct in 53.7%, 49.4%, 48.5%, and 49.3% examinations, respectively. We compared each resident year with the year above as well as R1 to R4 residents to determine statistical significance between each year of training. All comparisons were not statistically significant.
Conclusions: As a resident progresses and gains more experience with colposcopy, improvement in accuracy of clinical diagnosis is expected. Our results show no difference in the proportion of accurate clinical diagnoses as the training year of the resident increases. This could correlate to a lack of formal nationwide colposcopic training, with a possible solution being to implement a colposcopy curriculum during residency.
Poster #024 The Roadmap of Human Papillomavirus and Cervical Cancer Prevention in Macau
Wong Kam Weng1, and Kin-Iong Chan1. 1Hospital
Objective: Controlling cervical cancer is certainly a top priority for most Asian populations. This study examines the available HPV epidemiological data in Macau with emphases on the unique features and possible effects on the application of HPV-based detection and preventive strategies.
Methods: Macau follows ASCCP’s recommendation to implement regular cervical cytology. All reports are recorded in the centralized electronic database of Health Bureau.
Results: 11,469 cases were referred for colposcopy examination from 2007 to 2016. The split of result was: HPV infection 43%, CIN I 33%, CIN 2 10% CIN 3 11% and ICC 3%. Cervical cancer rank #5 in 2007, whereas in 2015 the rank has decreased to #8 in female malignancy tumor. Per 100,000 crude incidence rate was 11.3 in 2007, 7.7 in 2015 respectively. HPV 16, 18, 45 and 52 were the most frequent single infection types in invasive cervical cancer samples, whilst HPV 52 infection was found the most prevalent in Macau. First peak of HPV infection was found in the younger age group 20–25 years old, interestingly, a second peak was found for older women 51–55 years old.
Conclusions: This epidemiological characteristic for HPV infections in Macau should be considered when evaluating the performance of cytology screening program since 1997, introduction of HPV co-testing (Roche-4800) as primary screening in 2017, and in assessing the impact of national HPV vaccine program in 2013 and 9-valent HPV vaccine program in 2017.
Poster #025 Factors Contributing to Non-Adherence of Follow-Up in Patients Attending Colposcopy and LEEP Clinic
Lisa Spiryda1 and Katherine Baker2. 1University of South Alabama, COM, 2University of Florida
Objective: Understanding the factors contributing to lack of patient follow-up is an important first step in improving patient adherence and therefore outcomes in patients with an abnormal Pap smear test. Examine the factors contributing to non-adherence to scheduled colposcopy and LEEP clinic follow-up in patients with abnormal Pap smear results.
Methods: This was a retrospective study of women scheduled to either colposcopy or LEEP clinic following referral for an abnormal Pap smear. Data was collected by chart review from the time period of 4/1/2015 until 3/13/2017 and statistical analysis was performed to identify predictors of lack of follow-up. Factors assessed including patient age, race, type of referral (internal versus external), distance to clinic, type of insurance, referring Pap smear diagnosis, history of positive Pap smear results, and if patient was pregnant at time of Pap smear.
Results: The study identified 100 colposcopy clinic patients and 28 LEEP clinic patients for a total of 128 patients that were non-adherent to follow up. Average patient age was 35 years old with 48.0% African American, 41.0% Caucasian, and 8.6% Hispanic patients. There were equal numbers of internal and external referrals. The average distance to clinic was 29.6 miles. The referring pap diagnoses were distributed as 6.3% ASCUS with negative HPV, 30.5% ASCUS with positive HPV, 35.2% LSIL, 18.8% HSIL, 1.6% AGS, 7.0% positive HPV only, and 0.8% unsatisfactory result. Analysis indicated that distance to clinic was the only factor associated with non-adherence to follow up in colposcopy clinic. Older age was the only factor associated with non-adherence of follow up to LEEP clinic.
Conclusions: Distance to clinic was related to non-adherence of follow-up to colposcopy clinic. Older age was associated with non-adherence of follow-up to LEEP clinic.
Poster #026 Cervical Screening and Colposcopy Management of Women Ages 24 and Under
Rachel Kupets1, Li Wang2, Julia Gao2, Anna Kone3, and Nathaniel Jembere2. 1University of Toronto, 2Cancer Care Ontario, 3lakehead University
Objective: In many jurisdictions age of initiation of screening is 21 years, and women ages 21–24 with cervical dysplasia are considered special population who should be managed conservatively. The purpose of this study is to assess cervical cancer screening and colposcopy management for women ages 24 and under.
Methods: A population based retrospective cohort study linked Registered Personal Database to screening cytology data and health care administrative databases from 2012 to 2014 by women’s unique health number.
Results: Among 270,391 Pap tests performed, age distribution for women ages 12–17, 18–20 and 21–24 were 5.5%, 24.3% and 70.1%. The trend revealed a decreasing proportion of women ages 12–20 who had a Pap test: 36.7% of cohort in 2012 to 15.2% in 2014. 58.7% of Pap smears were performed by female physicians and 78.9% by family physicians. 87.0% of Pap smears were normal; 12.1% low grade; 0.5% high grade. Of index LSIL smears, referral rates to colposcopy in ages 12–17, 18–20 and 21–24 were 21.8%, 45.1% and 51.4% respectively. Of index HSIL smears, referral rates to colposcopy in ages 12–20 and 21–24 were 81.1% and 91.4%. In women ages 12–20 and 21–24 rate for carcinoma in situ were 41.9 and 393.5 per 100,000 women, while the rates were 0.3 and 2.4 per 100,000 for cancer.
Conclusions: Screening and treatment of very young women with cytologic abnormalities is still occurring despite low underlying risks of serious dysplasia. Over-referrals of low-grade Pap results to colposcopy need to be reduced.
Poster #027 Evaluation of Colposcopy Services in an Organized Cervical Screening Program: Is it Time for Colposcopy Indicators?
Rachel Kupets1, Michelle Policarpio2, Janet Heng2, Nathaniel Jembere2, and Julia Gao2. 1Toronto-Sunnybrook Regional Cancer Center, 2Cancer Care Ontario
Objective: To determine the quality and timeliness of Ontario's colposcopy services based on select cancer screening indicators for 2014 and 2015.
Methods: We conducted a population-based analysis of Ontario women, 21–69 years, who received subsequent colposcopy in 2014 and 2015 using healthcare utilization data. Measures included median wait time (in days) from index high grade Pap test to colposcopy; proportion within wait time guidelines; and, proportion who went directly to colposcopy from first-time ASCUS. Descriptive statistics were used to summarize screening data while Pearson Chi-square Test was used to assess proportions (p<0.05 was considered as statistically significant).
Results: The median wait time from the date of index high grade Pap test to initial colposcopy decreased from 62 to 55 days from 2014 to 2015. Median wait time varies by region. The proportion of women receiving colposcopy within the recommended wait times also vary by index Pap smear abnormality. A significant improvement was observed in the proportion of women seen for colposcopy within the recommended wait times for ASC-H and HSIL Pap test results (p<0.001). The overall proportion of women who were seen for colposcopy after one ASCUS Pap smear was 6% in 2014 and 2015. Results vary by age group but the proportion has been stable over the two-year period.
Conclusions: There is room for improvement in terms of wait time and first-time ASCUS indicators in the province. For a screening program to be effective, appropriate and timely colposcopy service is extremely important. Further strategies are required to monitor and improve Ontario's colposcopy services and eventually, reduce the burden of cervical cancer in Ontario.
Poster #028 Does Forced Cough Minimize Pain at the Time of Colposcopic-Guided Biopsy?
Theresa Kuhn1, Adanna Ukazu1, Lisa Pompeo1, Natalie Roche1, Dawn Goldstein1, and Mark Einstein1. 1Rutgers - New Jersey Medical School
Objective: To assess the efficacy of cough compared to no cough for pain relief at the time of colposcopic-guided biopsy.
Methods: This is an ongoing randomized placebo-control study of women who are in need of colposcopy, excluding pregnant patients or those with pelvic malignancy. Patients are assigned to a cough or no cough group in a 1:1 randomization, with assigment chosen using randomization envelopes. Based on retrospective study data, a pre hoc power analysis determined 55 women are required per arm to detect a difference of 0.9 cm on a standardized visual analog scale. Patients in both arms are asked to rate their pain on a visual analog scale at multiple procedure points.
Results: A total of 35 patients have been enrolled to date, 17 in the cough group and 18 in the no cough group. There is no significant difference in pain scores between the cough and no cough group before the procedure (1.06+/−2.28 compared with 1.17+/−1.82, p=0.878), at speculum insertion (3.06+/−2.88 compared with 2.44+/−2.99, p=0.541), at the time of biopsy (3.882+/−3.238 compared with 3.972+/−3.491, p=0.938) or after the procedure (2.53+/−2.70 compared with 2.50+/−2.64, p=0.974). Multivariable linear regression analysis shows an inverse relationship of pain with number of live births, vaginal deliveries, and history of prior colposcopy (p=0.007, p=0.032, p=0.49). Updated statistics with recent accruals will be presented if accepted.
Conclusions: Forced cough during colposcopic-guided biospy does not provide significant pain relief, nor does it cause worsening pain. This may be due to an underpowered study. We will reanalyze the data, including potential cofounders, after 110 patients have been enrolled as per the power analysis.
Poster #029 Colposcopy Training in Residency: A Survey of Obstetrics and Gynecology and Family Medicine Program Directors
Crysten Cheatwood1 and Michael Gold1. 1Oklahoma State University
Objective: To gather information regarding the amount and method of colposcopy training received by OBGYN and Family Medicine (FM).
Methods: An anonymous survey querying the methods of resident colposcopy education and feedback was sent to all U.S. OBGYN and FM residency program directors via Survey Monkey. Chi-square and T-Test were used to evaluate the statistical significance of responses.
Results: The overall response was small, with 59 completed surveys (29 OBGYN and 30 FM). 27 were from community based programs and 32 were from university based programs. 98% of respondents train residents in colposcopy. Regularly scheduled, dedicated colposcopy clinics were significantly more common in OBGYN (p=0.02). OBGYN reported more hours in colposcopy clinics (57 vs. 22 hours; p=0.001). Similarly, OBGYN reported performing more colposcopies (110 vs 11; p=0.0001). Community programs were more likely to rely on resident continuity clinics for colposcopy education (p=0.02). 87% of program directors believe their program could use improvement and 68% are interested in a formal didactics curriculum provided by the ASCCP. 38% believe there should be a formal certification process for colposcopy in their specialty.
Conclusions: There is a broad range of colposcopy experiences between OBGYN and FM residency programs, as well as community and university based programs. A desire exists for ASCCP to develop a formal resident curriculum.
Poster #030 Correlation Between Cervical Cytology, Colposcopy, Biopsy and Human Papillomavirus Genotypes by PCR
Alessandra Godoy1, Isnard Elman Litvin1, Mariana Vetturazzi de Souza1, and Francisco Bertelli Ramos1. 1UCS
Objective: The aim of this study was to establish the relation between results of the polymerase chain reaction (PCR) for HPV-DNA type with cervical cytology, colposcopy and biopsy.
Methods: A retrospective study, in database of PCR for HPV-DNA, involving 86 patients with abnormal cervical cytology was conducted in 2016. The analyzed topics were: patient’s age, cervical cytology, biopsy of the colposcopy, PCR for HPV-DNA.
Results: Eighty-six patients presented abnormal cytology. HPV-DNA was positive in 59 (68,6%) cases. Multiple HPV infection was found in 33 (38,4%) cases. The most prevalent genotypes were: HPV16, HPV51, HPV58, HPV6, HPV31 e HPV11. Twenty one patients with cytology ASCUS had HPV not detected, 3 (14,3%) of them had low-grade lesion (LSIL) on the biopsy. Eleven patients with cytology ASCUS had single HPV infection, 4 (36,4%) of them had LSIL and 1 (9,1%) HSIL on the biopsy. Thirteen patients with cytology ASCUS had multiple HPV infection, 10 (76,9%) of them had LSIL and 1 (7,7%) had HSIL on the biopsy. Multiple HPV infection obtained more LSIL and HSIL on the biopsies.
Conclusions: Multiple HPV infection might be related to an increased risk of LSIL and HSIL. The high prevalence of HPV16, HPV6 and HPV11 in this study shows the importance of immunizations’ programs, since these genotypes are covered by the vaccine. However, HPV genotypes that are not covered by the vaccine showed important prevalence. Thus, this information highlights the inclination of a genotypic redistribution with the increasing number of women infected by not covered genotypes.
Poster #031 Pregnancy Reasonably Excluded Guide for Pregnancy Screening Prior to Colposcopy
Margaret Long1, Claire Brutocao1, and Amy Weaver1. 1Mayo Clinic
Objective: Recommended pre-colposcopy evaluation includes assessment of pregnancy status. Pregnancy Reasonably Excluded Guide (PREG) provides a patient centered process for identifying known pregnancy (Dx pregnancy) and focusing pregnancy (hCG) testing on women with more pregnancy potential. In a provider confirmed, patient self-reported format, PREG pulls together traditional criteria for hCG test exclusion and WHO criteria for reasonably excluding pregnancy. This study compares pre-colposcopy pregnancy evaluation after PREG with documentation prior to implementation.
Methods: The study included women aged 18–50 undergoing outpatient colposcopy during either of two 6-month periods before and after PREG. Colposcopy records from pre-PREG period were reviewed for exclusion criteria (menopause, tubal ligation, onset menses <7 days ago, Dx pregnancy). In the PREG period, pregnancy exclusion criteria and Dx pregnancy were obtained from the pre-colposcopy PREG checklist. PREG included additional criteria of: reliable use of hormonal contraception, partner vasectomy, IUD, contraceptive implant, and no coitus with male since normal menses. Rates of hCG test exclusion and Dx pregnancy were compared between the two periods using Chi-square.
Results: 378 were in the pre-PREG period and 245 during PREG. PREG criteria were available on 239 (97.6%). hCG testing was traditionally excluded in 20.1% (60.8% if contraceptives included) in pre-PREG period and by PREG in 79.2% of all women in the PREG period (p<0.001 for both). Of 35 with hCG test directed by PREG, 20 had negative tests and others not tested. With PREG 87.3% had specific criteria documenting pregnancy status.
Conclusions: PREG consistently and efficiently evaluates for pregnancy prior to colposcopy.
Poster #032 HPV Genotype Distribution of Human Papillomavirus in Chinese Women With Various Abnormal and Normal Cervical Pap Tests
Chengquan Zhao2, Baowen Zheng1, Jia You1, and Zhengyu Zeng1. 1Kingmed, 2UPMC
Objective: The data for HPV genotype distribution in women with normal and abnormal cervical Pap tests is very limited in China.
Methods: HPV genotyping results in women with Pap tests in 2015 at KingMed Laboratory were retrospectively analyzed. HPV genotypes were performed using 26 HPV Genotyping Panel Kit from Tellgenplex (TELLGEN Shanghai, China).
Results: 12291 women with HPV genotyping results (18 HR and 8 LR types) were included. The prevalence of HR-HPV was 86%, 73.1%, 67.9%, 30.7%, 11.7% in women with HSIL, LSIL, ASC-H, ASCUS, and normal Pap cytology, respectively. HPV16 is the most common type in women with HSIL (45%) and ASC-H (39%), and the second most common type in LSIL (12%), ASCUS (15%), NILM (13%), while HPV52 is the most common type in LSIL (28%), ASCUS (27%) and NILM (24%), the second most common In HSIL (24%), ASC-H (24%) Paps. HPV58 is the third most common type in ASC-H and ASCUS Paps, and the fourth cost common type in HSIL, LSIL and NILM. HPV18 counts less percentage in all categories. Single HRHPV infection accounted for 76% and 83.6% HRHPV positive cases in women with abnormal Pap and normal Pap tests, respectively (p<0.05%).
Conclusions: These data can provide the value to understand the HPV epidemiology and to guide for vaccine selection for Chinese women.
Poster #033 Histopathologic Follow-Up and HPV Test Results With LSIL Pap Test Results in China’s Largest Academic Woman’s Hospital
Xiang Tao, Hao Zhang2, Jianan Xiao2, Xianrong Zhou2, Li Wang2, and Chengquan Zhao3. 1Obstetrics and Gynecology Hospital of Fudan University, 2University of Pittsburgh Medical Center
Objective: Cervical cancer remains a major health problem in China, where no uniform national standards for cervical cytology quality control exist. The study investigates histopathologic outcomes as well as HPV testing results of LSIL cervical cytology results in China’s largest women hospital.
Methods: A retrospective cohort study documented LSIL Pap tests, age, HPV results, and histopathologic follow-up from 2011–2016 in the Obstetrics and Gynecology Hospital of Fudan University (OGHFU) in China. Pap test methods include ThinPrep, SurePath and conventional Pap (CP) and HPV test methods include HC2, Cervista, and cobas 4800.
Results: During the study period, 1,095,022 Pap test were performed. Overall LSIL reporting rate was 1.4%, significantly higher in Liquid-Based Cytology (LBC) (1.5-1.6%) than with CP (0.5%). Among 8,079 cases with histopathologic follow-up (6 months), CIN1 was diagnosed in 4,681 cases, CIN2/3 was diagnosed in 11.9% and carcinoma in 0.3%. Of 3,371 cases with LSIL Pap and HPV testing result, HPV positive rate was 63.5%, with HC2 66.9%, Cervista 74.3%, and Cobas 61.4%, respectively (p<0.05). 196 of 1,462 patients with HPV-positive LSIL (13.4%) had a follow-up histopathological diagnosis of CIN 2+ (CIN2 and above). One hundred and five of 909 patients with HPV-negative LSIL (11.6%) had CIN 2+ detection in the follow-up, including 6 invasive cervical cancers. In older women group CIN2+ detection rate in the cases with negative HPV test was significant lower than that in the cases with LSIL/positive HPV test (Table).
Conclusions: It is the largest cases study for women with LSIL Pap tests in China. HPV test could be helpful for LSIL women 50 years and older, stratifying them into lower-and higher risk groups for follow-up histological CIN2/3 outcomes. It is surprising that 11.6% women with LSIL/negative HPV testing had histological CIN2/3 (including 6 invasive cancers), which indicates that HPV testing as the primary screening will miss the diagnosis of these women with precancer.
Poster #034 Outcomes of Conservative Management of Adenocarcinoma In Situ and Risk for Progression to Invasive Adenocarcinoma
Siddhartha Das1, Marette Lee2, Kathy Ceballos2, and Mark Carey2. 1,2University of British Columbia
Objective: Women who want to preserve fertility may elect for conservative management of adenocarcinoma in situ (AIS) by excisional therapies. Given the subsequent risk of developing invasive cancer of about 7%, robust post treatment management is critical. The management protocol in the study region includes a combination of cytology, high risk HPV testing and colposcopy with biopsy/endocervical curettage for at least 5 years. Our objective was to evaluate conservatively managed cases that progressed to invasive disease with the goal to identify opportunities to improve management guidelines.
Methods: A search was performed of regional cancer registry data to identify women who had pathological diagnosis of “adenocarcinoma in situ” and/or “invasive adenocarcinoma” from January 2008 to June 2016.
Results: A total of 69 cases were found. Of these, 41 had an initial diagnosis of invasive disease. Of the 28 with AIS, 7 were eventually treated with definitive management (hysterectomy), 17 are still being followed, and 4 met our criteria for progression to invasive disease. Adherence issues were identified in each of these cases including patient refusal of treatment; patient non-adherence with follow up; care provider failure to repeat excision after initial positive LEEP margin; and care provider failure to offer hrHPV testing and early discharge of the same patient.
Conclusions: All cases of progression occurred in the context of a protocol violation and may have been avoided if patients and providers had adhered to management protocols. Further investigation and comparison with cases who did not progress to invasion may elucidate whether progression to invasion is associated with protocol violations.
Poster #035 HPV and Hepatitis C Prevalence and Knowledge Among MSMs in Monrovia Liberia, Using Community Peer-Educators.
Ann Marie Beddoe2, Christopher Reynolds1, Molly Lieber2, Whitney Lieb2, and Stephen McGill3. 1,2Icahn School of Medicine at Mount Sinai, 3Stop AIDS in Liberia (SAIL)
Objective: To determine human papillomavirus (HPV) and Hepatitis C (HCV) prevalence, knowledge, and interest among men who have sex with men (MSM) in Monrovia, Liberia.
Methods: Thirteen peer-educators at an HIV/AIDS advocacy center recruited 107 MSMs, administered HCV and HPV interviews, and facilitated rapid HCV and anal HPV self-screenings. Participants’ knowledge scores were categorized: excellent (>75% correct), satisfactory (50-75%), poor (25-50%), very poor (<25%).
Results: The peer-educator model was effective in recruiting and providing a safe environment. Accountability among peer-educators was challenging, requiring daily interviewing and confidentiality refresher trainings. HPV prevalence was 45%; no participant tested positive for HCV. Participants demonstrated limited knowledge of both diseases; only 10.3% and 1.9% fell in the excellent category while 29% and 48.6% answered all questions incorrectly, for HCV and HPV, respectively. HPV and HCV knowledge scores were significantly correlated (r=0.664, p=0.000); more knowledge of one disease was associated with more knowledge of the other. HPV knowledge was not correlated with prevalence, indicating that higher knowledge was not associated with likelihood of having HPV. Participants demonstrated significant interest in health educational opportunities. Majority (96%, 95%) indicated desire for HCV and HPV education workshops, respectively. Nearly 80% expressed interest in receiving the HPV vaccine.
Conclusions: The peer-educator model was successful in mobilizing participants and disseminating information. Among MSMs, HPV prevalence is high while HPV and HCV knowledge levels are very low. Participants were eager to receive HPV and HCV health information, and future studies should analyze whether education before screening yields greater participant recruitment.
HPV Screening and Management
Poster #036 Atypical Glandular Cells on Pap Tests and Non-Gynecologic Malignancies
Lisa Spiryda1, Laura Alsina2, Gloria (Gigi) Lipori3, and Elizabeth (Ely) Plasencia2. 1University of South Alabama, COM, 2University of Florida, 3University of Florida Health
Objective: Atypical Glandular Cells(AGC) on Pap tests make up approximately 0.4% of all Pap smear results but can be associated with premalignant or malignant lesion in up to 30% of cases. There are several case studies that show both extrauterine (ovarian, fallopian) and non-gynecologic cancers like colon and breast malignancies were diagnosed through work up of AGC Pap. The objective of this study was to determine if there is an association between AGC Pap tests and non-gynecologic malignancies.
Methods: IRB exempt status was obtained for this retrospective chart review. 51 Charts were identified. Data abstracted included: Demographics, pathology/cytology from cervical biopsies, ECC and endometrial biopsies, medical history. Statistical analysis was performed using JMP Statistical Software ©SASInstitute Inc.
Results: Race/ethnicity distribution was 67% White, and 19% Black women with a mean age of 48.4. 69% had a prior abnormal Pap test; 23.5% HPV positive. As part of the initial work-up 41% did not have a colposcopy, 12% had no ECC and 20% had no endometrial biopsy. 11.7% were diagnosed with a uterine malignancy; 10 % a non-gynecological malignancy which were evenly mixed between hematologic, primary breast, metastatic breast, skin, and GI. When data was stratified/analyzed by age and race/ethnicity, there was no differences type of malignancies. One unexpected finding was that all women < 30 years old had an ECC performed whereas women > 30, 16% did not have ECC and 16% had no endometrial biopsy performed despite part of standard work-up.
Conclusions: AGC Pap smear should prompt immediate and thorough evaluation given risk of high grade lesions and malignancy. If initial workup not consistent with expected lesions or recurrent AGC Pap smear, consider extrauterine malignancies in differential diagnosis.
Poster #037 The Impact of Extended Interval Cervical Cancer Screening Guidelines on the Annual Exam
Mary Baylon1, Deborah Bartholomew1, Erinn Hade1, Courtney Lynch1, and Yubo Tan1. 1Ohio State University
Objective: New guidelines were released in 2012 for the prevention and early detection of cervical cancer for ages 30–65, which include a reduction in the total number of screening tests and a preference for co-testing using cytology and HPV status. The purpose of this retrospective cohort study is to investigate whether these guidelines have had an impact on return rates for annual preventive exams.
Methods: All women, ages 30–65, seen for an annual gynecological exam in 2011 were included. Women who had a history of an abnormal Pap, history of hysterectomy, or were pregnant during the study period were excluded. In 2012, patients were given education regarding the new recommendations. The change in the proportion of repeat visits over time was assessed through Modified Poisson regression models.
Results: Of the 215 patients seen in 2011 at a suburban faculty clinic with a majority being white and ages 40–65, nearly all returned in 2012 (99%). After introduction of the new guidelines in 2013, the rate of return decreased significantly compared to the return rate in 2011 and 2012. The rate of return decreased by nearly 30% in 2013 (aRR: 0. 71, 95% CI: 0. 66, 0. 78). By 2014, only 63% of women were returning annually.
Conclusions: Fewer patients appear to be returning for an annual gynecological exam following the introduction of the new cervical cancer screening guidelines. Whether this association is causal remains unknown. Gynecologists should consider educating their patients on the importance of returning annually to address important aspects of their preventative healthcare.
Poster #038 If Persistent HPV Infection Causes Disease, Why Are We Not Measuring It?
Laurence Vaughan1, Jeff Andrews1, Douglas Malinowski1, Valentin Parvu1, James Harris1, Brian Faherty1, Alexis Fakner1, Zhang Kang1, and Bill Nussbaumer1. 1BD Diagnostics
Objective: There is universal agreement that HPV is required for the development of cervical disease and that HPV-induced disease is associated with a persistent High-Risk HPV infection. The introduction of organized cervical cytology screening programs has resulted in a marked reduction in cervical cancer morbidity and mortality. Here, the relative insensitivity of cytology to detect disease was offset by the serial nature of the screening paradigm, where disease [resulting from persistent infection(s)] was often detected over several screening rounds. Many countries are now shifting to primary HPV screening using extended screening intervals. As we embark on this transition, the irony is that we seem to be ignoring some basic first principles of cervical cancer screening, namely the ability to monitor persistent HPV infection directly using extended genotyping (beyond HPV 16/18).
Methods: Here we argue that extended genotyping information provides a unique and necessary insight into a woman’s risk for developing disease using examples from the recent literature and US-PMA trial.
1. It enables the physician to detect persistent infections which have a higher disease risk
2. It can guide management decisions, especially in short-term follow up scenarios
3. It enables comprehensive test of cure to be performed on treated women (not just for HPV 16/18)
4. It can identify non-HPV16/18 types with an increased CIN3 risk (e.g. HPV 31, 33 and 45) versus just recording “other-high-risk” infections, enabling them to be tracked over time
5. It provides critical information for downstream “risk-based colposcopy” follow up
6. It provides important information on vaccinated women with reduced HPV16/18 disease burden
We also demonstrate that extended genotyping overcomes one of the primary deficiencies of the 12-other HPV pool screening approach, namely the inability to accurately assess a patient’s CIN3 risk due to masking (when 2 or more HPV types with different absolute risks result in a pooled average risk that is an underestimate of the highest individual genotype risk).
Conclusions: We conclude that extended genotyping permits an expansion of HPV testing to include all elements of risk management: (i) the detection of prevalent CIN3+ disease; (ii) estimating the 3-year risk for future CIN3+; and (iii) permitting unambiguous detection of persistent infections as another indicator of clinical risk.
Poster #039 Test of Cure: Using Extended Genotyping, Compared to Limited Genotyping or Qualitative: From a Systematic Review
Salma Kodsi1 and Jeff Andrews1. 1BD Diagnostics
Objective: Two systematic reviews of hrHPV testing after treatment of CIN2+ were published in 2012. Two narrative reviews of hrHPV testing after treatment of CIN2+ were published in 2016. Guidelines for post-treatment management utilizing extended genotyping (xGT) have not been published.
Methods: The Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, PubMed, and the Health Technology Assessment database were searched from 2001 through 2017 for relevant controlled trials and observational studies. Hand-searching of retrieved article reference lists supplemented the search. Eligible studies included prospective studies of women and retrospective studies of residual specimens from women that were tested using HPV xGT assays after treatment of CIN2+.
Results: A PRISMA flow diagram is presented for this systematic review. Thirteen original research articles met inclusion and exclusion criteria. Reporting xGT results provides discrimination of same genotype persistence or clearance or new infection. The results support risk-based clinical action decisions. Models for different management paradigms are described.
Conclusions: The role of same genotype persistence is critical to test of cure assessments. Guideline panels may decide to include reporting by individual genotypes for post-treatment surveillance. The information in this report is intended to help guideline panels, policymakers, clinicians, and women make informed decisions about the selection of health care services, is intended as a reference, and not as a substitute for clinical judgment.
Poster #040 Reducing Unnecessary Colposcopy By Risk Discrimination. HPV Genotyping & NILM & Low-Grade Cytology: Systematic Review
Jeff Andrews1. 1BD Diagnostics
Objective: Guideline originators have not yet included an analysis of the body of science published recently about the clinical value of extended HPV genotyping (xGT) in cervical cancer screening and triage, and in follow-up of women with abnormal results, needed to support recommendations.
Methods: PubMed, Cochrane Database of Systematic Revews, and Health Technology Assessment database were searched from 2001 through 20017 for relevant studies. Hand-searching of retrieved article reference lists supplemented the search. Eligible studies included prospective studies of women and retrosepctive studies of residual specimens from women that were screened or tested using HPV genotyping tests and had cytology results of NILM, ASC-US, or LSIL. The reference standard was CIN2 or CIN3 or CIN2+ or CIN3+ or invasive cervical cancer. The timeframe for follow-up studies was 6-months or 12-months, and unlimited for persistence tracking.
Results: A PRISMA flow diagram is presented for this systematic review. Twenty-two original research articles met inclusion and exclusion criteria. Reporting xGT results provides discrimination of both current and future CIN2+ risks. xGT could be utilized as triage in all screening paradigms to discriminate risk and support risk-based clinical action steps by the principle of similar management for similar risk. xGT could be utilized as follow-up of type -specific persistence versus clearance, to support risk-based clinical decisions.
Conclusions: Guideline panels must decide whether to separate reporting by individual genotypes or to group genotypes with similar risks into risk tiers. Similar management for similar risk-discrimination is benchmarked.
Poster #041 Examining the Clinical Impact of “Similar Management for Similar Risk” in Cervical Cancer Screening
Jeff Andrews1 and Caitlin Asjes1. 1BD Diagnostics
Objective: While 14 HPV genotypes are classified as carcinogenic, it is well established that the risk of cervical cancer progression varies by genotype. HPV 16 and 18 are described as having the highest risk, however research demonstrates that other genotypes have similar CIN3+ risk to 18. This study utilized a model to predict the impact of “similar management for similar risk”: managing 45, 31, 33, and 58 similar to 18.
Methods: A health economic model was created utilizing disease and genotype-specific prevalence data from the BD Onclarity Clinical Trial and published literature from the US. HPV primary screening with only 16/18 direct referral to colposcopy and cytology triage for all other HPV types (standard of care (SOC)) was compared to 16/18/45/33/58 direct referral with cytology triage for other types (comparator). The preliminary model compares results over 1 screening round.
Results: Results suggest that the comparator strategy would lead to 12% more cancer detection and 43% less CIN3+ missed than the SOC. While colposcopies would increase by 34%, colposcopy efficiency would only decrease by 5%. 67% more high risk genotypes would be referred to colposcopy and 95% fewer lower risk genotypes would be referred immediately.
Conclusions: New assays are becoming available which can provide results based in individual HPV genotypes. Moving from pooled HPV results to more specific results allows for clinicians to individualize patient management at the initial screen. These preliminary results indicate that individualized management could improve patient outcomes in the US.
Poster #042 The Clinical and Economic Impact of Incorporating HPV Extended Genotyping in Cervical Cancer Screening Strategies
Jeff Andrews1 and Caitlin Asjes1. 1BD Diagnostics
Objective: Cervical cancer screening programs aim to detect pre-cancer while avoiding overtreatment. HPV extended genotyping (XGT), genotyping beyond 16 and 18, may support these aims, potentially improving patient management via individual risk stratification. This model aims to predict the potential clinical and economic impact of adding XGT into the multiple existing screening algorithms.
Methods: A budget impact model was created utilizing disease and genotype-specific prevalence data from the BD Onclarity Clinical Trial and published literature from the US. The model analyzes the impact of utilizing individual high risk-HPV genotyping to manage patients as opposed to pooled HPV assays alone. Screening scenarios considered include Co-testing and HPV primary.
Results: Preliminary results demonstrate the use of XGT has the potential to increase cervical cancer and CIN2+ disease detection. While between 20-34% more colposcopies may be performed, these would be in the women with the highest risk genotypes. Up to 95% less colposcopies would be performed in women with genotypes that have low CIN2+ risk and who can be safely followed-up again in a year. There would be a slight increase in initial screening costs but a decrease in treatment costs under a XGT scenario.
Conclusions: XGT can be incorporated into either co-testing or HPV primary screening to improve disease detection and allow for individualized patient management. Further research into the longer-term impact of XGT is recommended since additional economic efficiencies and patient benefits overtime are expected both from utilizing XGT for persistence tracking and to respond to the effects of vaccination.
Poster #043 Role of p16/Ki-67 Testing as a Triage Testing After Primary Screening for Cervical Cancer
Yucong Li1 and Qi Zhou1. 1 CSCCP
Objective: To evaluate the performance and application value of p16/ki-67 testing as a triage testing after primary screening for cervical cancer.
Methods: 2182 sexual active women between 35–64 years were screened for cervical cancer in Wanzhou district, Chongqing. It is a regional prospective study which based on HPV ai primary screening. All women were screened by HPV testing. A total of 229 HPV postive women were tested for liquid-based cytology and p16/ki-67 on residual ThinPrep material.Then all HPV positive women were referred for colposcopy. If no visible lesion was found,endocervical curettage was performed. The final diagnose was based on pathological findings.
Results: The colposcopy referral rate,sensitivity,specificity and positive predictive vale of primary screening with HPV for detecting HSIL and invasive cervical cancer were 11.6%, 93.5%, 86.2% and 22.3%, respectively. After HPV primary screening, the referral rates of two strategies of triage with liquid-based cytology and p16/Ki-67 were decreased to 4.8% and 5.9%, respectively; the sensitivity values were decreased to 82.6% and 83.9%, respectively; the specificity values were increased to 96.1% and 94.3%, respectively; the positive predictive values were increased to 39.2% and 32.7%, respectively. The difference of AUC between HPV primary screening and its combination with the triage of liquid-based cytology and p16/Ki-67 was not statistically significant.
Conclusions: p16/Ki-67 testing is promising as a triage testing among women with positive screening findings in low-resourse setting,especially in areas where experienced cytopathologist is not available.
Poster #044 Effect of a Coriolus Versicolor-Based Vaginal Gel in HPV+ Women With No Colposcopy Cervical Lesions. A Pilot Study
Luís Serrano1, Silvia González1, Julio Gálvez2, Alba Rodríguez Nogales2, Teresa Vezza2, José Garrido Mesa2, Francesca Algieri2, and María Elena Rodríguez Cabezas2. 1Gabinete Médico Velázquez, 2Center for Biomedical Research (CIBM), University of Granada
Objective: To evaluate the effect of a Coriolus versicolor-based vaginal gel (Papilocare®) on cervical epithelialization and vaginal microbiota in positive-HPV women with no colposcopy lesions.
Methods: An exploratory, prospective, observational study. Sexually active positive-HPV women aged > 25y with negative pap and no colposcopy cervical lesions were included during routine clinical visits and treated with Papilocare® once daily for 21 consecutive days. Primary endpoint: change vs baseline in epithelialization degree of the cervix mucosa evaluated by standard colposcopy and rated by investigator from 5 = No ectopy o 1= severe ectopy and bleeding. Secondary endpoints: 1) changes in vaginal microbiota (diversity and proportion of both bacterial phyla and species) were evaluated by pyrosequencing; 2) changes in vaginal signs and symptoms evaluated by likert-type scale from 7= severity to 28= absence; 3) patient satisfaction.
Results: 21 patients were included. Papilocare® showed a positive trend to improve the re-epithelialization of the cervix: mean score improved 20% (3.79 vs 4.47 baseline vs final; T test p<0.006). 52.6% of patients improved cervix epithelialization and a score of 5 was observed in 63% of women. Concerning vaginal microbiota, both a reduction in vaginal diversity (4 vs 2.5, Shannon index baseline vs final; T test p<0.006) and an increase of proportion of Firmicutes (phylum to which the lactobacilli belong) were shown. Specifically, significant increase of Lactobacillus crispatus and iners was observed (T test p<0.005). A trend to improve symptoms was observed despite of few symptoms at baseline: 71% of patients reached maximum symptoms score at the end of treatment period. Eight patients improved the symptoms score and 3 worsened. A “moderate/complete satisfaction” and some degree of “positive impact on wellness” were reported by 84% and 90% of evaluated patients, respectively.
Conclusions: In this pilot study, Papilocare has demonstrated to improve significantly the cervix epithelization among HPV-positive women without cervical lesions. Treatment was able to reduce the microbiome diversity, clear marker of vaginal dysbiosis. The increase concentration of specific species of the genus Lactobacillus (iners and crispatus) suggests a restoration of the altered microbiota composition at the end of the study. These results might explain the mechanism of action of Papilocare in providing positive results on normalizing cervical lesions; these findings need to be confirmed in a larger study.
Poster #045 A New Sequencing-Based Assay Combining HPV Detection and Identification With Vaginal Microbiome Analysis
Elisabeth Bik1, Sara W. Bird1, Luis E. Leon1, Juan A. Ugalde1, Daniel E. Almonacid1, Jessica Richman1, and Zachary S. Apte1. 1uBiome
Objective: The vaginal microbiome composition has important associations with a woman’s reproductive and general health. Yet, most healthcare providers focus on the detection of high-risk human papillomavirus (hrHPV), the predominant cause for cervical cancer. Not all women participate in these programs, presumably out of reluctance to undergo a pelvic exam. Offering women the possibility of self-sampling might improve compliance. Here, we describe SmartJaneTM, a new test that combines self-sampling with sequencing-based HPV detection and type determination, vaginal microbiome analysis, and detection of pathogens involved in sexually transmitted infections.
Methods: Based on a literature search, bacterial targets with clinical relevance for women’s reproductive tract health, as well as HPV targets were selected. The performance of the targets was assessed using synthetic DNA fragments, while the hrHPV detection was evaluated against the Digene HPV HC2 assay. The assay was then applied to self-sampled vaginal specimens.
Results: SmartJaneTM can detect 32 bacterial targets, including Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, and Treponema pallidum. Healthy ranges of each target were determined on a healthy cohort of 100 women. In addition, the assay can detect and identify 19 hrHPV types with a sensitivity of >90% and 5 lrHPV types.
Conclusions: The intended use of the SmartJaneTM assay is to complement conventional cervical cancer screening. Its self-sampling format might lead to higher responses in women who would otherwise not participate in these programs, and thus lead to decreased incidence of cervical cancer, while at the same time offering additional information about the composition of the vaginal microbiome and the presence of pathogens.
Poster #046 Prevalence of Cervical High-Risk Human Papillomavirus Infection in Ningxia Province, China
Andrew Goldstein2, Ameila Goldstein1, Lena Goldstein1, Alyssa Savelli3, Roberta Lipson4, and Annie He4. 1McDonogh School, 2Center for Vulvovaginal Disorders, 3Virginia Tech Carillon School of Medicine, 4United Family Hospitals
Objective: Cervical cancer is the number one cause of gynecologic cancers in developing countries with the vast majority of cases caused by the human papillomavirus (HPV) [1, 2]. Logistical and economic issues make traditional cytology-based screening challenging in developing countries. Testing for high-risk HPV (hrHPV) is an effective method for cervical cancer screening in low-resource settings. The careHPVTM (QIAGEN, Gaithersburg, MD) tests for 14 hrHPV genotypes . Our study analyzes the prevalence of HPV in Ningxia Province, China as detected by the careHPV system.
Methods: Women ages 30 to 70 underwent self-sampling hrHPV screening in August 2017 in Ningxia Province, China.
Results: Of 1,127 women screened, 100 (8.9%) were found to be positive for hrHPV.
Conclusions: This study is the first to report the prevalence of cervical hrHPV among women in Ningxia Province, China using the careHPVTM system. The population of Ningxia is diverse with 36% of people being ethnic minorities  and is predominantly Muslim . Our screening reported a lower prevalence (8.9%) of active HrHPV infections in this province as compared to China as a whole (14.3%). This difference may be attributed to the conservative sexual practices of the largely Muslim population in Ningxia. Patient-collected samples allowed for efficient screening. Detection rates in patient-collected samples have been shown to be equal to physician-collected samples in previous studies .
Poster #047 Self-Sampling HPV Testing Combined With Digital Cervicography in a See-and-Treat Cervical Cancer Screening Program
Lena Goldstein1, Ameila Goldstein1, Andrew Goldstein2, Roberta Lipson3, and Annie He3. 1McDonogh School, 2Center for Vulvovaginal Disorders, 3United Family Hospitals
Objective: Logistical and economic issues make traditional cytology-based cervical cancer screening challenging in developing countries. Alternative screening methods have been developed. This study examines the combination of self-sampling HPV testing with the careHPVTM system (Qiagen, Maryland) in combination with digital cervicography (DC) with the EVATM system (MobileODT, Israel).
Methods: Women underwent self-sampling HPV screening. High-risk positive (HR+) women then underwent DC. Women with suspected carcinoma underwent biopsy. Women with suspected high-grade dysplasia (HGD) underwent LEEP. Women with suspected low-grade dysplasia (LGD) had cryotherapy.
Results: 1,127 women in Ningxia, China performed self-sampling HPV testing. 100 women were HR+ and subsequently had DC after the application of acetic acid. 12 of the 24 women with suspected LGD underwent confirmatory cervical biopsy. 10/12 (83%) of these biopsies confirmed CIN 1. All women suspected of having LGD subsequently underwent cryotherapy. Two women with suspected carcinoma were biopsied and both biopsies confirmed invasive carcinoma. Three women who had suspected HGD underwent LEEP. All three LEEPs confirmed CIN 3.
Conclusions: The careHPV system allows rapid and inexpensive detection of HR+. DC helps to distinguish between probable low and high-grade cervical dysplasia and is therefore superior to visualization with acetic acid. In addition, by performing DC only in HR+ women, both the sensitivity and specificity of DC are likely improved. DC also allows women with probable HGD to have a LEEP rather than cryotherapy. The combination of self-sampling HPV testing and subsequent DC of HR+ women is an efficient and cost effective see-and-treat screening cervical cancer screening strategy.
Poster #048 Screening Methods for Diagnosis of Cervical Diseases in Outpatients
Chao Zhao1, Li Geng2, Yun Zhao1, Yanli Guo2, Ke You2, and Lihui Wei1. 1Peking University People's Hospital, 2 Peking University Third Hospital
Objective: To evaluate the screening methods for diagnosis of cervical diseases.
Methods: Women who underwent opportunistic screening for cervical diseases and colposcopy was studied. Colposcopy and biopsy were performed for women who showed abnormal results from either cytology or high-risk HPV testing. Diagnostic results from cytology, HR-HPV testing, and co-testing were compared and analyzed by χ2 test, using SPSS 17.0.
Results: A total of 7406 women recruited during this four years. The HSIL lesion diagnosed by co-testing (99.27 %) was higher than that of hr HPV test (97.39 %) and cytology (84.60%). Cervical cancer diagnosed by co-testing (98.10 %) was higher than that of hr HPV test (90.51 %) and cytology (86.71%). 5,351 women showed abnormalities with liquid-based cytology (≥ ASC-US); colposcopy confirmed advanced cervical diseases (≥ CIN2) in 1914 women, and the sensitivity and specificity of liquid-based cytology for advanced cervical diseases (≥ CIN2) were 84.01% and 31.85%, respectively; the positive and negative predictive value (PPV and NPV) were 30.05% and 85.11%, respectively. In total, 6,184 and 1222 women showed positive and negative results for high-risk HPV testing. The sensitivity and specificity for diagnosis of advanced cervical diseases (≥ CIN2) were 92.06% and 19.67%. The PPV and NPV were 29.82% and 86.99%, respectively. 4,793 women were positive for co-testing with liquid-based cytology and high-risk HPV testing. The sensitivity and specificity of co-testing for diagnosis of advanced cervical diseases (≥ CIN2) were 98.86% and 16.64%; the PPV and NPV were 32.46% and 97.29%, respectively.
Conclusions: Co-testing with liquid-based cytology and high-risk HPV screening showed increased sensitivity, PPV and NPV, indicating the usefulness of this method in clinical opportunistic screening for cervical diseases.
Poster #049 Trends in Cervical Cancer Screening and Adherence to New Guidelines in Tennessee, United States Women, 2006–2014
Manideepthi Pemmaraju1, Han-Zhu Qian2, Sheelah Iyengar1, Stephanie Allen1, Edward Mitchel1, and Marie Griffin1. 1Vanderbilt University Medical Ce, 2Centers for Disease Control and Prevention
Objective: Major changes in United States cervical cancer screening guidelines in 2009 culminated in consensus recommendations in 2012 that included no screening for women younger than 21 and 65 years or older, and screening every 3–5 years for women ages 21–64. We examined annual cervical cancer screening, and adherence to the new guidelines among Tennessee women.
Methods: We identified women ages 18 and older, enrolled in Tennessee Medicaid (TennCare) 2006–2014, with Current Procedural Terminology codes indicating Papanicolaou (Pap) smear screening and human papillomavirus (HPV) detection tests. We evaluated annual Pap smear testing rates among all women and adherence to new screening guidelines among women ages 21–64.
Results: There were 440,988-495,909 women enrolled in TennCare annually, 2006–2014. Pap screening rates declined in all age groups from 2009–2014. Additionally, 54.1% of women adhered to the new guidelines of either Pap smear every 3 years (ages 21–64) or Pap plus HPV co-testing every 5 years (ages 30–64). While adherence rates were 75.8%, 70.7%, 60.5% and 38.9% among women ages 21–24, 25–29, 30–39 and 40–64, respectively, declines were observed after 2012.
Conclusions: Among low income Tennessee women, new cervical cancer screening guidelines were associated with expected declines in screening among women younger than 21 and 65 and older, but adherence to appropriate screening every 3–5 years for women ages 21–64 appeared to decline as well.
Poster #050 Outcomes of HPV Positive Results in Women Following Primary Cervical Cancer Screening With HPV DNA Test in Singapore
Li Min Lim1, Jeffrey Low1, Joseph Ng1, Ilancheran Arunachalam1, Evelyn Koay1, Esther Yu1, and Ida Ismail-Pratt1. 1National University Hospital
Objective: Negative HPV screening has a strong negative predictive value; however there has been no standardized management of women with positive HPV. The aim of this study is to identify outcomes of women with positive oncogenic HPV.
Methods: This is a retrospective study of women who underwent HPV testing as part of cervical cancer screening between 2013 and 2016 in a tertiary institution in Singapore.
Results: Cervical cancer screening was performed in 3971 women.Â Co-testing was done in 2827 (58.1%) and HPV primary screening in 1144 (23.5%). There were 3730 negative results (93.9%), 42 positive HPV 16 (1.1%), 15 positive HPV 18 (0.4%), 183 positive non 16/18 (4.6%). One had positive result for both HPV 16 and 18 (0.02%). Of the 42 positive HPV 16, 5 had biopsy-proven CIN2+. Six patients (14.3%) had clearance of HPV between 6–24 months. One patient had a negative diagnostic LEEP. Of the 15 positive HPV 18, 3 had biopsy-proven CIN2+. Three patients (20%) had clearance of HPV at 12 months. Two patients had negative diagnostic LEEP. One patient had both HPV 16 and HPV 18 positivity underwent diagnostic LEEP and histology was negative. Of the 183 positive non 16/18 HPV results, 8 had biopsy-proven CIN2+. There was documented clearance of HPV in 48 patients (26.2%) over a range of 6–36 months.
Conclusions: While HPV DNA tests can increase detection of high grade CIN, there is a need to strike a balance between increased sensitivity and overtreatment that may lead to recognized future fertility implications.
Poster #051 Human Papillomavirus Vaccinations in Singapore: Are We Targeting the Right Population?
Li MinLim1, Judith Ong1, Jeffrey Low1, Joseph Ng1, Ilancheran Arunachalam1, and Ida Ismail-Pratt1. 1National University Hospital
Objective: Human papillomavirus (HPV) vaccinations plays a crucial role along with screening in cervical cancer prevention. Singapore currently does not have an HPV school vaccination program. We aim to analyse the cohort of women who received vaccinations at our institution.
Methods: This is a retrospective study of all women who underwent HPV vaccination for cervical cancer prevention in the gynaecology department in a tertiary institution in Singapore between 2013 and 2015.
Results: Between 2013 and 2015, the number of women between 9 to 26 years eligible for the HPV vaccine attending for various other gynaecological reasons was 7835. Out of these, 326 (4.2%) received HPV vaccinations. A total of 518 women of all ages underwent HPV vaccination. Majority of women had the quadrivalent vaccine (87.6%) and the rest (12.4%) had the bivalent vaccine. 62.9% of women were aged 26 years and below, while 37.1% of women were more than 26 years at the time of the first vaccine dose. More than half of the women were sexually active at the time of vaccination (57.5%) while 42.5% were virgo intacta. Less than half the population completed the entire vaccination schedules (44.3%). 7.9% of women had abnormal cervical smears prior to the start of the vaccination schedule.
Conclusions: The current HPV vaccination approach in Singapore is not targeting the right population of women for cervical cancer prevention. A school based HPV vaccination program needs to be seriously considered to allow for optimal protection against cervical cancer in Singaporean women.
Poster #052 Age of Initial Sexual Behaviour Among Females and Awareness of the HPV and the HPV Vaccine in Jiangsu Province, China
Hongyun Wang1, and Ying Hong1. 1Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing
Objective: This survey was created primarily to obtain comprehensive and accurate information regarding the age at which women in Jiangsu initiated sexual behaviour and to determine different groups’ knowledge about human papilloma virus (HPV) and the HPV vaccine in Jiangsu province of China. The goal of collecting this information is to determine the best age at which to inoculate Chinese women with the HPV vaccine and to promote the use of the vaccine in China.
Methods: The survey was administered in urban and rural areas to 1320 randomly selected people from three categories: women in Jiangsu (aged 15–59 years), health workers and government staff. Information was collected through questionnaires, and the collected data for each group were compared to determine knowledge of HPV and the HPV vaccine in Jiangsu province, China.
Results: 1. More than 70% of the women Jiangsu province reported initiating sexual behaviour between the ages of 19 and 26 years. Urban and rural women did not significantly differ in this regard.
2. The respondents had better knowledge of the national vaccine immunization programme than the non-national immunization program, but fewer than 20% knew about the non-national immunization plan for rural women.
3. Other than the medical workers, the respondents had generally not heard of HPV or the HPV vaccine; among the medical workers, half had not heard of the HPV vaccine.
4. The vast majority of respondents (over 80% urban and rural women) were willing to have themselves (or their spouse) and their daughters vaccinated against HPV.
5. The main reason for being unwilling to vaccinate was that the vaccine has not been widely used, followed by concerns about the safety and efficacy of vaccines.
6. Regarding an acceptable price for the vaccine, 83% of the medical staff, 88 % of government staff and 80% of the urban women selected 1500 yuan of Renminbi (RMB) (225 US$) or less, while nearly 90% of the rural women selected less than 1000 yuan of RMB (150 US$) or less.
7. Regarding preferred vaccination sites, more than 40% selected vaccination site at the Centres for Disease Control (CDC) of China ; 33.13% of the rural women were willing to visit community service centres, and 29.09% of the urban women selected a general hospital.
8. In most parts of China, cervical cancer screening begins at age 30 years. More than 30% of the women from Jiangsu province reported undergoing gynaecological examinations once a year; more than 50% of women reported undergoing gynaecological examinations when they were sick, and less than 20% of women did not undergo gynaecological examinations.
Conclusions: It is suitable that the HPV vaccine for girls in the age group of 9–13 years for WHO recommends because of initiating sexual behaviour between the ages of 19 and 26 years in Jiangsu Province. Regarding an acceptable price for the vaccine, the urban women selected 1500 yuan of Renminbi (RMB) (225 US$) or less and the rural women selected less than 1000 yuan of RMB (150 US$) or less. The vast majority of respondents were willing to have themselves (or their spouse) and their daughters vaccinated against HPV. Regarding preferred vaccination sites, more women selected vaccination site at the Centres for Disease Control (CDC) of China, the rural women were willing to visit community service centres, and urban women selected a general hospital.
Poster #053 HPV Vaccination Among Young Adults: Findings From a Cross-Sectional Statewide Survey
Deanna Teoh1, Rebekah Nagler1, Rida Shaikh1, Rachel Isaksson Vogel1, Abigain Schnaith1, Emil Lou1, Shalini Kulasingam1, and Annie-Laurie McRee1. 1University of Minnesota
Objective: Catch-up vaccination against human papillomavirus (HPV) is recommended for older adolescents and young adults to age 26. We sought to describe HPV vaccination coverage among young adults using data from a statewide sample.
Methods: This IRB-approved anonymous, cross-sectional survey was conducted at the Minnesota State Fair during August and September 2017. Fair attendees 18–26 years of age were invited to participate. We used chi-square analyses to identify demographic associations with initiation (≥1 dose) and series completion (3 doses).
Results: Of 1,037 respondents, 637 (61%) had received at least 1 dose of HPV vaccine, and 303 (29%) had completed the series. HPV vaccine initiation was higher among respondents who were: younger (age 18–22 vs. age 23–26 years-old; 63% vs. 59%, p=0.0002); female (73% vs. 43%, p<.0001); white (vs. non-white; 62% vs. 55%; p=0.006). Only 31% reported receiving a recommendation for the HPV vaccine from a healthcare provider, however, provider recommendation was significantly associated with vaccine initiation in all subgroups. Series completion was higher among females (54% vs. 30%; p<0.0001). The most common reasons for not being vaccinated were: not receiving a provider recommendation (35%), lack of information (34%), or being in a monogamous relationship (30%).
Conclusions: HPV vaccination coverage remains suboptimal among young adults. Efforts are needed to support effective provider recommendations to 18–26 year-olds, especially non-white men who are the least likely to report HPV vaccination.
Poster #054 A Community Based Assessment of HPV Vaccination Prevalence in High-Risk Women in Chicago
Jessica Madrigal1, Lisa Henry-Reid1, and Ashlesha Patel1. 1John H. Stroger, Jr. Hospital of Cook County
Objective: We aimed to determine HPV vaccination rates among women living in an urban community and to identify barriers to vaccination.
Methods: A trained health educator collaborated with community-based organizations to host health education sessions for young women in Chicago. Forty-nine sessions took place at 17 sites over two years. Attendees had a brief one-on-one encounter with the educator about sexually transmitted infections (STI), plus an interview about prior STI testing and HPV vaccination. We used contingency tables and logistic regression to determine factors associated with HPV vaccination.
Results: Of the 311 women who received education at a community session, 291 answered questions about history of HPV vaccination. Women were 17 (SD=2.3) years old, 62% (n=182) African American, and 33% (n=96) Hispanic. Only 11.3% (n=33) previously received the HPV vaccine, and only 18 received multiple doses. Most were unsure of their health insurance status. Eighty-five women (29%) reported receiving STI testing in the previous two years, and 64% (n=183) had a primary care physician. In an adjusted model, prior STI testing was associated with 3.7 times higher odds (95% CI 1.4, 9.5, p=0.007) of being vaccinated compared to women who did not receive prior STI testing.
Conclusions: Our study provides evidence that young minority women living in Chicago may have low rates of HPV vaccination. Women who received prior STI testing (i.e., sought healthcare) were more likely to be vaccinated relative to their peers who did not have testing indicating that racial, ethnic, or socioeconomic disparities may inhibit access to preventative services for these women. Further investigation into barriers and facilitators to vaccination in this group is necessary.
Poster #055 A Zebra in the Gynecologist’s Office: Multisystem Langerhans Cell Histiocytosis Presenting as Vulvar Ulcers
Christa Dominick1, Renuka Lakshminarayanan1, and Nell Suby1. 1Kaiser
Objective: Langerhans Cell Histiocytosis is rare, with initial presentation as vulvar ulcers being even more unexpected. The broad spectrum of presentations leads to misdiagnoses and inappropriate treatments. We conducted this study to review experiences with this disease, increase awareness and to describe methods of diagnosis.
Methods: Methods: We identified one patient at our institution who initially presented with bilateral vulvar ulcers who was later found to have Multisystem Langerhans Cell Histiocytosis. A retrospective chart review and comprehensive review of the literature were conducted.
Results: Langerhans Cell Histiocytosis occurs in approximately 1–2 per 1 million adults. Median latency time to diagnosis is 4 months, with an interquartile range of 0–22 months, but in 5% of cases it spanned 10 years to make a diagnosis. Patients have been misdiagnosed and mistreated for other diseases including candida, herpes and vulvar cancer. Langerhans cells are large cells with abundant pink cytoplasm and a bean-shaped nucleus on hematoxylin and eosin. A definitive diagnosis can be made with clinico-pathological evidence with microscopic exam and at least one of the following immunological staining: Langerin (CD 207) positivity, CD1a positivity, or presence of Birbeck granules on electronic microscopy.
Conclusions: Langerhans Cell Histiocytosis should be included in the differential diagnosis of disease of the vulva. Misdiagnoses can result in treatments that pose significant risks topatients. This emphasizes the importance of early and accurate diagnosis. It is important thatgynecologists are aware that this disease can appear similar to a variety of vulvar disorders inorder to facilitate early diagnosis.
Poster #056 Are We “Choosing Wisely” When Screening Patients With Endometrial Cancer for Recurrent Disease?
Aaron Nizam, Karin Shih1, Lisa dos Santos1, Antionette Sakaris1, John Lovecchio1, Jill Whyte1, Marina Frimer1, Gary Goldberg1, and Andrew Menzin1. 1Northwell Health
Objective: To describe the utilization and trends in the use of vaginal cytology in women with endometrial cancer at our institution from 2012–2016. In 2013 the ABIM Foundation released the “Choosing Wisely” initiative recommending the avoidance of vaginal cytology in endometrial cancer survivors.
Methods: We performed a retrospective analysis of all women presenting for outpatient surveillance in the month of August from 2012–2016. Medical records were reviewed to determine if vaginal cytology was performed as part of the routine surveillance in patients with a diagnosis of endometrial cancer. The decision to perform vaginal cytology was made by the attending physician.
Results: Between 2012 and 2016 a total of 423 visits occurred for survivorship in patients with endometrial cancer. The frequency of vaginal cytology performed for the screening of recurrence decreased from 67.1% to 13.4% (Figure 1, p < 0.05) during the study period. There was no relationship between the grade of the disease, the stage of the disease, or a history of recurrence in women where vaginal cytology samples were taken (p > 0.05). Both older age at the time of endometrial cancer diagnosis and older age at the time of office follow up were associated with vaginal cytology being performed (p < 0.05).
Conclusions: Our study suggests that practicing health care providers are following evidence-based guidelines for the outpatient surveillance for recurrence in patients with endometrial cancer. This has resulted in a decrease in unnecessary procedures for patients and decreased healthcare spending.
Poster #057 The Clinical Analysis of Fractional CO2 Laser in the Treatment of Vulvar Lichen Sclerosus
Jingran Li, Yali Miao1, Jianliu Wang1, and Li-Hui Wei1. 1 Peking University People's Hospital
Objective: To investigate the efficacy and side effects for fractional CO2 laser in the treatment of vulvar lichen sclerosus (VLS).
Methods: 42 patients with VLS symptoms were enrolled prospectively from August 2015 to February 2017 in Peking University People's Hospital. VLS lesions was treated with fractional CO2 laser (SmartXide2; DEKA Laser, Florence, Italy), a total of 3 ~ 5 times, each time per-month. Visual analogue scale (VAS) was assessed the degree of vulvar pruritus, skin chapping, dyspareunia before and after treatment. After the treatment, satisfaction survey was done.
Results: The rate improvement of VLS symptoms was 90.47% (38/42) after treatment with fractional CO2 laser (P < 0.001).The pruritus score of vulva (6.75±1.79 vs. 1.78±1.36) were significantly lower than that before treatment (P < 0.05). The dyspareunia score (4.88±2.79 vs.2.15±1.29, P < 0.05) were improved significantly at the third after treatment one month. After treatment 24 h, there were 4 cases with mild pain, 6 cases with local mild hyperemia, 4 cases with mild swelling. No adverse events due to fractional CO2 laser treatment occurred. During 3 ~ 12 months follow-up, 6 cases (14.28%) with the skin color from white to gray, 6 cases recovered sex from 13 cases. The overall satisfaction rate was 95.23% (40/42).
Conclusions: The fractional CO2 laser is effective, minimal injury and acceptable side effects for vulvar lichen sclerosus, and may be a new treatment for it.
Undeserved Populations (Transgender, Homeless, Native American, etc)
Poster #059 Cervical Cancer Prevention: Perceptions and Practices at the University of Buea, Cameroon
Cortney Eakin1, Rodrigue Ekollo, MD2, Derick Nembulefack2, Gregory Halle-Ekane2, Gracious Tangui3, R. Brady4, and David Greenspan5. 1Maricopa Integrated Health Sys, 2University of Buea, 3Cameroon Baptist Convention Health Services, 4St. Joseph Hospital, 5University of Arizona
Objective: To determine knowledge and utilization of cervical cancer screening among a university population in Buea, Cameroon.
Methods: In this pilot program, a public-private partnership was established between the University of Arizona, University of Buea and the Cameroon Baptist Convention Health Services (CBCHS). A one-day screening clinic using visual inspection with acetic acid (VIA) and Lugol’s solution (VILI) was provided at the Univeristy Student Health Center. Screening impressions were documented as negative, low-grade, high-grade or suspicious for cancer. Thermocoagulation was available for low-grade lesions. LEEPs were arranged at the Regional Hospital of Buea for high-grade lesions the following day. University faculty, staff and students were invited to participate. A short survey was conducted prior to screening.
Results: Of the 120 participants, three (2.5%) were HIV positive. The majority of women (65%) had 0–2 sexual partners in the past 5 years. Most participants (72%) had attained university level education. Ninety-five participants (79%) believed that treatment of precancerous lesions helped prevent cervical cancer, but most (65%) had never been screened. Seventy percent were aware of the HPV vaccine and only one had received vaccination.
Conclusions: Among an educated population in a low-income country, most participants believed that cervical cancer could be prevented with treatment of precancerous lesions and were aware of HPV vaccination. Despite this knowledge, the majority had never been screened or received vaccination. This study suggests a high desire for additional screening services in the Southwest Region of Cameroon and validates the need for continued public-private partnerships and outreach in underserved populations.
Poster #060 Knowledge of Cervical Cancer Screening Recommendations Among Clinicians in Publicly Funded Family Planning Clinic
Mona Saraiya2, Christina Fowler1, Kate Ahrens3, Sue Mokosky3, and Emily Decker3. 1Research Triangle Institute, 2CDC, 3Office of Population Affairs, Office of the Assistant Secretary of Health
Objective: Assess associations between health provider and clinic characteristics, including receipt of Title X funding, on providers’ knowledge of cervical cancer screening recommendations.
Methods: We used 2013–14 survey data from a national sample of 1,312 publicly funded family planning clinics, where a health provider in each clinic answered knowledge- and practice-related questions associated with the Providing Quality Family Planning Services recommendations. Knowledge of cervical cancer screening recommendations was measured by identification of the recommended starting age for routine screening (21 years) and screening interval for an average-risk 25 year-old (every 3 years). We examined knowledge differences across clinic- and provider- level characteristics by Title X funding status.
Results: Compared to providers in clinics that received no Title X funding, a higher percentage of providers in Title X-funded clinics had knowledge of the recommended starting age (94% vs. 86%, p<.01) and interval (70% vs. 56%, p<.01) for cervical cancer screening in average-risk women. Overall and by selected clinic and provider characteristics, knowledge of the recommended screening interval was lower than knowledge of the starting age.
Conclusions: Publicly funded clinics are a regular source of health care for low-income women who are at higher risk for inadequate cervical cancer screening. To ensure that women who seek care from publicly funded family planning clinics are screened according to the best available evidence, health providers’ knowledge of current cervical cancer screening recommendations can be improved, especially in clinics that do not receive Title X funding.
Poster #061 Identifying Pitfalls of a Pap Smear Registry in An Urban Underserved Population
Sandricka Collier1, Au-Co Nguyen1, Molrine Tracey1, Elizabeth Philippe1, and Nicole Cook2. 1Community Health of South Florid, 2Nova Southeastern University
Objective: To determine if a pap smear registry would lead to improved follow-up care, patient compliance and treatment for cervical cancer in urban underserved women.
Methods: Through the development of a quality improvement (QI) project an inter-disciplinary team at a Teaching Health Center in Miami, Florida implemented a pap smear registry. The initiative aimed to identify compliance with clinic-wide follow-up of cervical cancer screening. Via a retrospective chart review of patients, the team reviewed all follow-up materials. 20 patients were then randomly selected for additional review. Inclusion criteria were women over age 21, with abnormal pap result of ASCUS and higher requiring follow-up colposcopy.
Results: Among the 20 cases the mean age was 36.3 years. 3 were currently pregnant. And 5 had coexisting HIV, of these 3 had a history of recurrent abnormal pap smears. All 20 had their results reviewed by the ordering provider (100%). Only three (15%) had their result tasked to an abnormal task pool for care coordination, though five others had care coordination performed by the provider’s care team. 9 were referred to outpatient gynecology facilities for follow-up. Only 2 of the 20 had evidence of the colposcopy being completed.
Conclusions: Review of a small sample of patients indicated that the pap smear registry alone was inadequate to ensure follow-up and the addition of a separate abnormal tracking pool and care coordination increased the likelihood of adequate management. To further determine the efficacy additional studies including those with a larger sample size are needed.
Vulvar Intraepithelial Lesions and Neoplasia
Poster #062 Is Cytology Destiny? Concordance of Cytology and Histology as Screening Tools for Vulvar Cancer
Laura Knabben1, Elke Krause1, Adriana Schwander1, Anja Schmitt Kurrer1, Mafalda Trippel1, Susanne Lanz1, Annette Kuhn1, and Michel Mueller1. 1University Hospital of Berne and University of Berne
Objective: The incidence of vulvar dysplasia/neoplasia increased throughout the past decades. Patients with increased risk need regular follow-up. Colposcopy belongs to the favoured methods but its sensitivity and specificity are uncertain, especially in patients with chronic vulvar diseases or after surgery +/− radiotherapy. In case of abnormality malignancy must be excluded by means of biopsy. Aim of the current study was to determine the accuracy of vulvar cytology to detect vulvar dysplasia in comparison to biopsy.
Methods: Retrospective analysis of data from patients who had a vulvar PAP smear, partly with a concomitant biopsy between 01/2012 and 12/2015. Concordance of vulvar cytology and histology was analyzed with Cohen’s Kappa.
Results: We performed vulvar cytology in 220 patients. Indications were acute symptoms in 42 (19.1%), screening in high-risk population in 40 (18.2%), follow-up after cancer in 61 (27.7%) or after cervical/vulvar dysplasia in 73 patients (33.2%). 174 (79.1%) PAP smears showed no pathology. 24 (10.9%) were classified as LSIL, four (1.8%) as HSIL one (0.45%) as carcinoma and 16 (7.3%) as ASCUS. One PAP was inadequate because of acellularity. In 61 (27.7%) women a concomitant biopsy was performed. 19 (31.1%) patients had a biopsy-proven vulvar dysplasia and 25 (41%) presented with benign lesions (e.g. Lichen sclerosus). Concordance analysis of cytological and histological results revealed moderate concordance with an observed agreement of 77.1% (k 0.49).
Conclusions: The negative predictive value of vulvar cytology was 87%. This indicates that vulvar cytology could be a screening tool for detection of vulvar dysplasia and thereby help to avoid unnecessary biopsies in the future. Our ongoing prospective trial will provide further evidence.Copyright © 2018 by the American Society for Colposcopy and Cervical Pathology