Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)
Overview
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).
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC [Time frame: Baseline (at enrollment)]
- Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC [Time frame: Baseline (at enrollment)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06115772 · 22-005420 · NCI-2023-04392 · 22-005420