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

Mayo Clinic

Status: Enrolling

Conditions: Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06115772

22-005420 (Other Identifier)

NCI-2023-04392 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

154 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study