This Phase II Cancer Control project will evaluate the feasibility of using filter in situ hybridization (FISH) for early detection of human papilloma virus (HPV) as a mass screening technique for females at higher risk of cervical and vulvar carcinomas. We will corroborate the sensitivity of FISH with Pap smears, coloscopy and/or biopsy results which are used currently as the standards for clinical and pathological assessment of normal/disease categories in cervical and vulvar lesions. A normal group of women (N=100) will be compared to groups of Cervical Invasive Carcinoma (N=87), Cervical Intraepithelial Neoplasia (N=41) (CIN), Vulvar Carcinoma (N=16) and Vulvar Intraepithelial Neoplasia (N=4) (VIN) for frequency of HPV types 6,11,16,18. Other potential risk factors will be compared between case categories and statistically associated with HPV DNA hybridization findings by group, using a self-administered questionnaire. Participants are comprised of women in Iowa, ages 20-79, Caucasian, who are seen at the University of Iowa Ob/Gyn and Gyn Oncology Clinics. The study proposes to compare reported sensitivity and specificity to our findings and to determine the PV+ of FISH for use in mass screening; to evaluate the efficacy with which genital specimens (smears and scrapings) can be collected by trained personnel during routine gynecologic exams for FISH assessment; to determine the costs/case; and to determine the feasibility of the laboratory technical effort required for using FISH as a mass screening technique. After testing the methodology and feasibility, we would develop a proposal to test the procedure (FISH) in a mass screening demonstration project (Phase V Cancer Control) in early detection of asymptomatic women at potentially high risk to genital carcinomas so they may be treated at an earlier stage; or so HPV+ women may be treated for these viruses to prevent dysplastic or carcinoma development. The use of the NCI Iowa-SEER cancer registry would present an ideal location for follow-up of disease development, as would the extremely low population mobility of the state.
