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

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: HPV(-) OPSCC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

154 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Kathryn M. Van Abel, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

Inclusion Criteria

Female patients with a positive diagnosis of Human Papillomavirus-associated Oropharyngeal Squamous Cell Carcinoma seen at the Mayo Clinic in Rochester.

You are the female partner of a Mayo Clinic patient with positive HPV-associated oropharyngeal squamous cell carcinoma.

Age ≥ 18

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants complete surveys, watch an educational video on HPV vaccination, and undergo collection of blood and saliva samples. Patients also undergo cervical screening per standard of care and may receive a referral to gynecology if not up to date on anogenital screening.

Baseline (at enrollment)

Follow-up

Participants are monitored for safety and effectiveness after the observational activities

4 weeks

Treatment Details

Participant Groups

Group I: Observational Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+