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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMayo Clinic

About 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

* 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

Disqualifiers

* HPV(-) OPSCC

Unable to provide informed consent

Unwilling to attend screening visit at Mayo Clinic site, if indicated

Unwilling/unable to complete surveys electronically

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

154 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (at enrollment)
2

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).

Time frame
Baseline (at enrollment)

Secondary outcomes

Other outcomes

Sponsors and contacts

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