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

NCT06115772 | Recruiting

• 2 other identifiers: 22-005420NCI-2023-04392
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC

  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).

  Baseline (at enrollment)

• Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC

  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).

  Baseline (at enrollment)

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients and female partners of patients with confirmed HPV associated oropharyngeal carcinoma (PAP-OP)

You may qualify if:

• \* 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

You may not qualify if:

• \* HPV(-) OPSCC
• Unable to provide informed consent
• Unwilling to attend screening visit at Mayo Clinic site, if indicated
• Unwilling/unable to complete surveys electronically

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Kathryn M. Van Abel, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)