NCT06115772

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 154 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2023-11-03
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States