1Director, Breast and Gynecologic Cancer, Cancer Control Science Department, American Cancer Society, Atlanta, GA, on behalf of the Steering Committee, Data Group, and Writing Committee; 2Senior Investigator, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Rockville, MD, on behalf of the Steering Committee; 3Adjunct Associate Professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA, on behalf of the Data Group; 4Deputy Physician in Chief, Medical Director, Memorial Sloan-Kettering Cancer Center Regional Network, Department of Surgery, Gynecology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, on behalf of Working Group 1; 5Assistant Professor, Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, on behalf of Working Group 1; 6Professor and Vice Chair, Department of Obstetrics and Gynecology, University of Massachusetts School of Medicine, Worcester, MA, on behalf of Working Group 2; 7Professor and Director, Center of Excellence in Women’s Health, Mel and Enid Zuckerman College of Public Health, University of Arizona at Tucson, Tucson, AZ, on behalf of Working Group 6; 8Director, Department of Esoteric Testing, AmeriPath Indiana, Indianapolis, IN, on behalf of Working Group 6; 9Professor, Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, on behalf of Working Group 3a; 10Professor of Pathology, Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, on behalf of Working Group 3b; 11Investigator, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD; 12Director, Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Women’s Health, Masonic Cancer Center, University of Minnesota Medical School, Minneapolis, MN, on behalf of Working Group 4; 13Professor of Clinical Obstetrics and Gynecology, Weill Medical College of Cornell University, New York, NY, on behalf of Working Group 4; 14Professor, Department of Pediatrics, University of California at San Francisco, San Francisco, CA, on behalf of Working Group 5; 15Professor, Departments of Oncology and Epidemiology, McGill University, Montreal, Quebec, Canada; 16Professor of Pathology and Clinical Gynecology, Associate Director of Surgical and Cytopathology, Surgical Pathology, Department of Pathology, University of Virginia Health System, Charlottesville, VA; 17Senior Investigator, Clinical Genetics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD; 18Executive Director, American Society for Clinical Pathology Institute, Washington, DC, on behalf of the Writing Committee; 19Professor, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC
Massachusetts General Hospital, Harvard Medical School, Boston, MA
Correspondence to: Debbie Saslow, PhD, Director, Breast and Gynecologic Cancer, American Cancer Society, 250 Williams St NW, Suite 600, Atlanta, GA 30303. E-mail: firstname.lastname@example.org
This article is jointly published in CA: A Cancer Journal for Clinicians, Journal of Lower Genital Tract Disease, and American Journal of Clinical Pathology by the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology.
*The last two authors are co-senior authors.
Disclaimers: The contents of the paper are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention, National Institutes of Health, the U.S. Government, or any medical or academic institutions.
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Disclosure of Conflicts of Interest
For this workshop and its planning phase, all participating committee and work group members were required to disclose all real or potential conflicts of interest including, but not limited to: association with relevant commercial interests, involvement with professional societies in an executive or policy making role, and the nature of their primary employment. Commercial interests were defined as any proprietary entity producing health care goods or services consumed by or used on patients (e.g., to include pharmaceutical companies, device manufacturers or distributors, service companies, or other for-profit entities).
The following reported no financial relationships or potential conflicts of interest to disclose: Debbie Saslow, PhD; Edward Partridge, MD; E. Blair Holladay, PhD, SCT; Walter Kinney, MD; Herschel W. Lawson, MD; Kenneth L. Noller, MD; Evan Myers, MD, MPH; Alan G. Waxman, MD, MPH; Kathleen Poole, MALS; Robert Smith, PhD; Patricia Fontaine, MD, MS; Abbe Herzig, PhD; Maureen Killackey, MD; Shalini Kulasingam, PhD; Dennis McCoy, Esq; Wendy R. Brewster, MD PhD; Joanna M. Cain; MD, David Chelmow, MD; Valerie J. King, MD; Robert G. Pretorius, MD; Barbara A. Winkler, MD; Isam A. Eltoum, MD, MBA; Jane J. Kim, PhD, MSc; Nico Wentzensen, MS, MD, PhD; Levi S. Downs, MD; Shirley E. Greening, MS, JD; HopeK. Haefner, MD; Laurie C. Zephyrin, MD, MPH, MBA; Harrell W. Chesson, PhD; Myriam Chevarie-Davis; Donatus U. Ekwueme, PhD; Terence J. Colgan, MD; Michael R. Henry, MD; L. Stewart Massad, MD; and Kate Simon, PhD.
Philip E. Castle, PhD, MPH, receives payment for service on the Data Monitoring and Safety Board for Merck Sharp & Dohme. Carmel Cohen, MD, serves as a speaker for Merck, Inc. and receives honoraria. The spouse of Mitchell Edelson, MD, is employed and receives salary from Merck, Inc. Francisco Garcia, MD, MPH, is employed by the University of Arizona, which holds contracts for the performance of research with Roche Pharmaceutical/Roche Molecular, Hologic, Third Wave, MTM, Qiagen, Becton Dickinson, and Medispectra/Luma. Dr Garcia also serves on the speakers’ list for Qiagen and receives honoraria. Jack Cuzick, MD, serves on advisory boards and as an ad hoc consultant for Qiagen, Roche, Gen-Probe, Becton Dickinson, and Abbott, with research fund provided to his institution from Qiagen, Roche, Gen-Probe, Becton Dickinson, and Abbott. Patti Gravitt, MD, provides service on the scientific advisory board from Qiagen and for which she received honoraria. Evan R. Myers, MD, MPH, received research support for investigations for Gen-Probe, Inc. and from GSK, Inc. He served as a speaker for and received honoraria from Gen-Probe, Inc. and has served as a consultant for Merck, Inc., for which he received an honorarium. Mark Schiffman, MD, MPH, holds a research agreement to serve as a medical monitor in the National Cancer Institute vaccine trial through GlaxoSmithKline; Dr Schiffman also receives research support from Qiagen for CareHPV research in Nigeria. Carolyn Runowicz, MD, serves on the board of directors for the American Society for Clinical Oncology and provides service on the scientific advisory board from Bayer for which she receives honoraria. Dr Runowicz has provided scientific review for and received payment from Precision Therapeutics, as well as served on the advisory board for Ovarian Cancer Research Fund (no payments received). Dr Runowicz is a paid reviewer for Champions Oncology, and she has received research funding from National Surgical Adjuvant Breast and Bowel Project. Diane Solomon, MD, serves as a medical monitor for the National Cancer Institute’s HPV Vaccine Trial in Costa Rica: the trial receives vaccine from GlaxoSmithKline. Mark H. Stoler, MD, received fees for serving as a consultant to Merck Research Laboratories, Roche, Ventana Medical Systems, Becton Dickinson, Hologic, MTM, and Gen-Probe. Richard S. Guido, MD, received research funds for services as the primary investigator on a multicenter study (contracted research and serves local PI) for IKONOBGYN. Dr Guido also received research funds to be a primary investigator on a multicenter study (local PI) for Hatt, Co. Dina R. Mody, MD, conducted lectures/workshops for both CAP and the American Society for Clinical Pathology and from which she received honoraria. Dr Mody received reimbursement for her travel expenses for conducting an ASC lecture/workshop. Jeffrey Waldman, MD, attended a consultants meeting for Graceway Pharmaceuticals and received an honorarium. The employer of George Birdsong, MD, receives funding for contracted research performed by Dr Birdsong for Becton Dickinson Diagnostics. Cosette Wheeler, PhD, is an employee of University of New Mexico, which is contracted by GlaxoSmithKline for its vaccine trials and for which Dr Wheeler serves as a principal investigator. Dr Wheeler also serves as a principal investigator employee of the University of New Mexico, which receives equipment/reagents from Roche Molecular Systems for human papillomavirus genotyping. J. Thomas Cox, MD, serves on the scientific advisory boards for Gen-Probe, Graceway, and Bradley Pharmaceuticals and receives honoraria for these services. Dr Cox also serves on the Data and Safety Monitoring Board and receives a fee from Merck, Inc; he was reimbursed for travel expenses for meetings of the Roche Data and Steering Committee. Dr Cox serves on the speakers’ bureau for Bradley Pharmaceuticals and has served to both speak and moderate at a symposium for Becton Dickinson Diagnostics; honoraria were received for these activities. David Wilbur, MD, serves on the scientific advisory board for Corista, LLC. Teresa M. Darragh, MD, received Thin Prep supplies for research from Hologic. She serves on an advisory board from OncoHealth and has received stock options as payment. Dr Darragh also serves on an advisory board for Arbor Vita Corporation and receives honoraria. Edward J. Mayeaux, Jr., MD, serves on the speakers’ advisory board for both Merck, Inc. and PharmaDerm, and he receives honoraria from both companies for his service. Mark Spitzer, MD, serves as a speaker for both Merck, Inc. and Qiagen and receives honoraria. He received an honorarium and royalties from Elsevier for book editorship; Dr Spitzer also received royalties as an author for the Colposcopy Image Library CD-ROM produced by SABK, Inc. Kevin A. Ault, MD, received clinical research grants from National Institute of Allergy and Infectious Diseases, GenProbe, Merck, Inc., and Roche and served as a site principal investigator for the research. All grants were provided to his employer, Emory University. Eduardo Franco, MD, received honorarium as a study steering committee member for GlaxoSmithKline; Dr Franco serves on the advisory boards of Merck, Inc., Roche, and Gen-Probe and from which he receives honoraria. Michael A. Gold, MD, received honorarium for serving as a speaker and consultant for Hologic. Warner K. Huh, MD, serves as a consultant to Roche, Qiagen, Merck, Inc., and Inovio and receives honoraria from all four companies. Anna-Barbara Moscicki, MD, received honorarium for serving as a consultant to an advisory board for Merck, Inc. Mark E. Einstein, MD, has advised or participated in educational speaking activities but does not receive an honorarium from any companies. His employer, Montefiore Medical Center, has received payment for his time spent on activities for Merck, Inc., GlaxoSmithKline, Roche, Bristol-Myers Squibb, Hologic, Advaxis, Aura Biosciences, Inovio, Photocure, Neodiagnostix, and PDS Biotechnologies. Montefiore Medical Center has received grant funding for research related to the costs of those Merck, GlaxoSmithKline, Roche, Advaxis, and Hologic clinical trials for which Dr Einstein served as the principal investigator of Montefiore Medical Center’s. Ann T. Moriarty, MD, received honorarium as a speaker for the American Society of Cytopathology; Dr Moriarty also receives a salary as compensation for her employment with AmeriPath.