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

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 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).

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 154

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Kathryn M. Van Abel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kathryn M. Van Abel, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 22-005420 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2023-04392 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No