Cervicography

Abstract: ContextMore than half of the women diagnosed as having cervical cancer in the United States have not been screened within the last 3 years, despite many having had contact with the health care system. In many other regions of the world, there is only limited access to cervical cancer screening.ObjectiveTo determine whether testing of self-collected vaginal swabs for human papillomavirus (HPV) DNA can be used to screen for cervical disease in women aged 35 years and older.DesignCross-sectional observational study comparing Papanicolaou smears with HPV DNA testing of self-collected vaginal swabs.SettingOutpatient clinics in a periurban settlement outside of Cape Town, South Africa, between January 1998 and April 1999.ParticipantsScreening was performed on 1415 previously unscreened black South African women aged 35 to 65 years.InterventionWomen self-collected a vaginal swab for HPV testing in the clinic and were then screened using 4 different tests: Papanicolaou smear, direct visual inspection of the cervix after the application of 5% acetic acid, cervicography, and HPV DNA testing of a clinician-obtained cervical sample. Women with abnormal results on any of the screening tests were referred for colposcopy.Main Outcome MeasureBiopsy-confirmed high-grade cervical squamous intraepithelial lesions or invasive cancer.ResultsHigh-grade squamous intraepithelial lesions were identified in 47 (3.4%) of 1365 women adequately assessed, and there were 9 cases of invasive cancer. Of women with high-grade disease, 66.1% (95% confidence interval [CI], 52.1%-77.8%) had high-risk HPV detected in self-collected vaginal samples, and 67.9% (95% CI, 53.9%-79.4%) had an abnormal Papanicolaou smear (P = .78). The false-positive rates for HPV DNA testing of self-collected vaginal samples and Papanicolaou smears were 17.1% (95% CI, 15.1%-19.3%) and 12.3% (95% CI, 10.5%-14.2%), respectively (P<.001). A high-risk type of HPV DNA was detected in 83.9% (95% CI, 71.2%-91.9%) of women with high-grade disease and 15.5% (95% CI, 13.6%-17.7%) of women with no evidence of cervical disease using a clinician-obtained cervical sample.ConclusionsThese results indicate that HPV testing of self-collected vaginal swabs is less specific than but as sensitive as Papanicolaou smears for detecting high-grade cervical disease in women aged 35 years and older, and HPV testing offers an important new way to increase screening in settings where cytology is not readily performed.

Abstract: OBJECTIVE: To describe the design and methods of the ASCUS-LSIL Triage Study (ALTS), a multicenter, randomized clinical trial designed to evaluate three alternative methods of managing low grade (LSIL) and equivocal (ASCUS) cervical cytologic diagnoses. STUDY DESIGN: Non-pregnant women, 18 + years old, with ASCUS or LSIL, no prior hysterectomy or ablative therapy to the cervix, were referred to one of four clinical centers around the United States. Eligible and consenting participants were administered a risk-factor questionnaire and underwent a pelvic examination, collection of cervical specimens for liquid-based cytology and human papillomavirus (HPV) testing and Cervicography (National Testing Laboratories, Fenton, Missouri, U.S.A.). Patients were randomized to one of three arms: (1) immediate referral for colposcopy at enrollment, (2) follow-up with cytology only, and (3) use of HPV DNA testing to triage to colposcopy. All women are followed every six months for two years with pelvic examinations, cytologic and masked HPV testing, and masked Cervicography, Digital cervical images and cytology and histology slides are externally reviewed to maximize patient safety. RESULTS: We enrolled and randomized 3,488 eligible women with ASCUS and 1,572 women with LSIL. CONCLUSION: The successful enrollment, randomization and high rates of follow-up are encouraging. The study will help clarify the optimal strategies for managing low grade cervical abnormalities.

Abstract: Section 1: Epidemiology and Public Health Aspects of Cervical Cancer: Human Papillomavirus and Cervical Cancer: Epidemiological Evidence Epidemiology of Cervical Human Papillomavirus Infection Geographical and Social Patterns of Cervical Cancer Incidence The Male Role in Cervical Carcinogenesis: Lessons from the Studies in Colombia and Spain and a Challenge for the Future Statistical Issues in Studies of Human Papillomavirus Infection and Cervical Cancer The Epidemiological Basis for Evaluating Screening Policies Prevention Measures in the Third World: Are they Practical? Prevention of Sexually Transmitted Infections through Health Education and Counselling: A General Framework Section 2: Natural History and Management of Cervical Cancer Precursors: Biological Behaviour of Cervical Intraepithelial Neoplasia Optimal Management of Cervical Cancer Precursors: Low Grade Squamous Intraepithelial Lesions Optimal Management of Cervical Cancer Precursors: High-Grade Lesions Glandular Lesions: An Increasing Problem Papillomavirus Infection and Neoplasia in Women Infected with Human Immunodeficiency Virus Section 3: The Cervical Cytology Paradigm: Performance of Cytology in Screening for Precursor Lesions and Early Cancer of the Uterine Cervix The Bethesda System (TBS): Advantages and Pitfalls Quality Assurance in Cervical Cytopathology Error Rates in Cervical Cancer Screening: Causes and Consequences Cervical Cancer Following Negative Smears Section 4: Cytology Screening Programmes: Organization, Monitoring and Use of Resources for Screening Programmes Cervical Screening by General Practitioners and Nurses and Information Feedback Systems Screening Programmes: Results and Expectations Screening for Cervical Cancer: Experience of the Nordic Countries Screening that Failed to Work Implementation and Evaluation of Cervical Cancer Screening Programmes in the European Union Organization and results of Cervical Cancer Screening in Europe Over the Past 20 Years Spontaneous Screening: Benefits and Limitations Is Cervical Cancer Cytological Screening Valuable in Developing Countries? Screening in Cervical Cancer Prevention in Porto Alegre, Brazil: The Experience of a Programme in a Developing Country Section 5: Automation in Cytology: Automation and Cervical Cytopathology: An Overview Automation in Cervicovaginal Cytology: System Requirements and Benefits Automated Screening using the AutoPap 300 Device Liquid-based Cytology: Comparison of ThinPrep 2000 with Conventionally Prepared Pap Smears The History of Neural Network Technology in Cytology A Comparison of Automated and Manual Screening: Theoretical Considerations Cooperation of the Image Analyser and the Cytologist Advantages and Limitations of Automated Screening Systems in Developing and Developed Countries Section 6: Human Papillomavirus Testing: Methods of DNA Hybridization and their Clinical Applicability to Human Papillomavirus Detection Human Papillomavirus Testing for Primary Cervical Cancer Screening Human Papillomavirus DNA Testing Using Liquid-based Cytology Human Papillomavirus Testing for Diagnostic Triage of Minor-grade Cytological Abnormalities: The European Perspective Use of Human Papillomavirus Tying for Quality Assurance of Cytological Diagnosis Estimates of the Cost Impact of Introducing Human Papillomavirus Testing into a Cervical Screening Programme Viral Load as a Surrogate for Persistence in Cervical Human Papillomavirus Infection Molecular Variant Analysis as a Tool in Natural History Studies of Human Papillomavirus Infection and Cervical Neoplasia Section 7: Adjunct Screening Tests: Evaluation of Multiple Screening Techniques in a High-risk Area: The Guanacaste Project Colposcopy as a Screening Tool for Cervical Cancer Detection: A Review Adjuvant Tests to Cytology: Cervicography and the Polarprobe Visual Inspection as a Screening Test for Cervical Cancer Control in Developing Countries Section 8: Prevention and Therapy by Immunization: Human Papillomavirus Vaccines and Their Potential use in the Prevention and Treatment of Cervical Neoplasia Animal Models for Evaluation of Human Papillomavirus Vaccines Induction of Human Papillomavirus-Specific Immune Response Section 9: Summary of Presentations and Consensus: Rapporteurs' Summary and Presentations Highlights and Consensus Index