Assessing HPV-related infections in women linked to throat cancer
Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)
This study is testing how common high-risk HPV infections are in women with throat cancer and their partners, while also looking at their sexual health and satisfaction with screening.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06115772 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of high-risk HPV infections and related anogenital lesions in women diagnosed with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) and their female partners. It will compare these findings with historical data from routine well-woman exams. The study also seeks to assess the sexual health and well-being of participants, develop standardized education for patients, and measure satisfaction with the screening process. Participants will complete surveys, watch an educational video, and undergo standard cervical screenings.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with newly diagnosed HPV-positive OPSCC and their female partners.
Not a fit: Patients with HPV-negative OPSCC or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of HPV-related health risks in women and improve screening and prevention strategies.
How similar studies have performed: While similar studies have explored HPV-related health risks, this specific approach focusing on female partners of OPSCC patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn M. Van Abel, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.