HPV Associated Cervical Disease

Development of an Algorithm for Cervical High-Grade Squamous Intraepithelial Lesion Based on Breath Print Analysis

Dokter, Laura A. MD¹; à Nijeholt, Jeanine H. MD¹; Rigterink, Bernadette M. MSc¹; de Lange, Natascha M. MD¹; de Haan, Harm H. MD, PhD¹; van Eijndhoven, Hugo W.F. MD, PhD¹; Joostens, Mieke MD¹; Kruse, Arnold-Jan MD, PhD^1,2,3

Author Information

¹Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, the Netherlands

²Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, the Netherlands

³GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Netherlands

Reprint requests to: Arnold-Jan Kruse, MD, PhD, Department of Obstetrics and Gynecology, Isala Clinics, PO Box 10400, 8000 GK Zwolle, the Netherlands. E-mail: [email protected]

Declaration of Interest: The e-Nose Company (Zutphen, the Netherlands) supplied an Aeonose, including software packages, filters, and mouthpieces, free of charge. Medical Specialists Company Isala (MSB Isala) invested in the eNose Company. AJK, NML, HHh, HWE, and MJ are members of MSB. The other authors have declared they have no conflicts of interest.

Ethics approval and data management: Regulatory approval was obtained from the institutional review board at Isala Clinics to undertake the study (June 29, 2020/registration number: 200626). All women provided written informed consent to participate.

Journal of Lower Genital Tract Disease 27(1):p 7-11, January 2023. | DOI: 10.1097/LGT.0000000000000707

Abstract

Objectives

This study was designed to develop an algorithm for the diagnosis of cervical high-grade squamous intraepithelial lesions (HSIL), based on patterns of volatile organic compounds, evaluated using an e-nose.

Methods

For this pilot study, the study population consisted of a group of 25 patients with histologically confirmed HSIL and a group of 26 controls. Controls consisted of women visiting the outpatient department for gynecological complaints unrelated to cancer. Women had a negative high-risk human papillomavirus and/or normal cytology (negative for intraepithelial lesions of malignancy) of their most recent test performed in the context of participation in routine cervical cancer screening. Breath tests were performed and labeled with the correct diagnosis. Machine-learning techniques were used to develop a model for predicting HSIL. Based on the receiver operating characteristics curve, both sensitivity and specificity were calculated.

Results

Individual classifications of all patients with HSIL and controls, as calculated by the model, showed a sensitivity of 0.88 (95% CI = 0.68–0.97) and specificity of 0.92 (95% CI = 0.73–0.99). The positive predictive value and the negative predictive value were 0.92 (95% CI = 0.72–0.99) and 0.89 (95% CI = 0.70–0.97), respectively. The Cohen κ coefficient was 0.80.

Conclusions

E-nose can detect distinctive patterns of volatile organic compounds between cervical HSIL patients and controls. Validation of the algorithm in further studies is necessary before possible implementation into daily practice.

Article Keywords

Keywords
high-grade squamous intraepithelial lesions, algorithm, electronic nose technology, breath analysis, volatile organic compounds, diagnosis

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Development of an Algorithm for Cervical High-Grade Squamous Intraepithelial Lesion Based on Breath Print Analysis