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Observational Study of HPV and Anogenital Pathology in Women

This study, called PAP-OP, is looking at how often women with throat cancer (oropharyngeal squamous cell carcinoma, or OPSCC) caused by Human Papillomavirus (HPV), or women who are partners of men with this type of cancer, also have HPV-related issues in their anogenital (anal and genital) areas. Researchers want to understand the incidence and prevalence of these HPV-related conditions at the start of the study. This is an observational study, meaning participants will be monitored without receiving any specific treatment as part of the study. The study aims to enroll 154 women. You may be able to join if you are a woman aged 18 or older with HPV-positive OPSCC, or if you are the female partner of someone with HPV-positive OPSCC, and are seen at Mayo Clinic, Rochester.

Study design
This is an observational study with a planned enrollment of 154 female participants. It is not a treatment study, but rather aims to understand the occurrence of certain conditions.
What's involved
Participants will complete surveys, watch an educational video, and provide blood and saliva samples. They will also undergo cervical screening as part of their usual care.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for incidence and prevalence of HPV-associated anogenital pathology are measured at Baseline (at enrollment).

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NCT06115772

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~154 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
Measured over Baseline (at enrollment)
+1 more outcome measured

Conditions

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Explore related trials

Oropharyngeal Squamous Cell CarcinomaHPV

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Kathryn M. Van Abel, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\* 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

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

What this trial measures

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

    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).

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

    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).