Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study
Purpose
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).
Condition
- Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- * Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester - Age ≥ 18 - Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC - Patient has given permission to give his/her blood/saliva sample for research testing - Ability to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria
- * HPV(-) OPSCC - Unable to provide informed consent - Unwilling to attend screening visit at Mayo Clinic site, if indicated - Unwilling/unable to complete surveys electronically
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational | 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. |
|
Recruiting Locations
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
Study Contact
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.