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Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)
This study evaluates how often women with throat (oropharyngeal) cancer or who have a partner with oropharyngeal cancer get anogenital infections with high risk, potentially cancer-causing types of human papilloma virus (HPV).
PRIMARY OBJECTIVES: I. Prospectively determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN. II. To determine the risk of requiring additional procedures or treatments secondary to these diagnoses. III. To determine the sexual health and well-being among patients and partners with HPV(+)OPSCC. IV. To develop standardized patient education and recommendations for referral and screening for this patient population. V. Measure patient satisfaction with study education and anogenital pathology screening process via internal questionnaire. OUTLINE: This is an observational study. Participants complete surveys, watch an educational video on HPV vaccination and undergo collection of blood and saliva samples on study. Patients also undergo cervical screening per standard of care and may receive a referral to gynecology if not up to date on anogenital screening.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
November 1, 2022
Primary Completion Date
November 1, 2027
Completion Date
November 1, 2027
Last Updated
February 23, 2026
154
ESTIMATED participants
Non-Interventional Study
OTHER
Lead Sponsor
Mayo Clinic
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