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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2027-11-01

Brief Summary

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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).

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Detailed Description

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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

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Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes