Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •* Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester
- •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
Arms & Interventions
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.
Intervention: Non-Interventional Study (Other)
Outcomes
Primary Outcomes
Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
Time Frame: Baseline (at enrollment)
Prevalence and incidence of human papilloma virus (HPV)-related anogenital disease in female patients with HPV-mediated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) will be compared to a population of patients with similar demographic and comorbidity status. Rates will be compared across groups using tests for proportional variables (Fisher's exact, Chi Square).
Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC
Time Frame: Baseline (at enrollment)
Prevalence and incidence of human papilloma virus (HPV)-related anogenital disease in female partners of HPV-mediated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) patients will be compared to a population of patients with similar demographic and comorbidity status. Rates will be compared across groups using tests for proportional variables (Fisher's exact, Chi Square).
Secondary Outcomes
No secondary outcomes reported