Clinical trial 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
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients and female partners of patients with confirmed HPV associated oropharyngeal carcinoma (PAP-OP)

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).

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.

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

Primary outcomes:
measure: Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
timeFrame: Baseline (at enrollment)
measure: Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kathryn M. Van Abel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: