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Trial 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
NCT ID:
NCT06115772
Condition:
Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
Female patients and female partners of patients with confirmed HPV associated
oropharyngeal carcinoma (PAP-OP)
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Kathryn M. Van Abel, M.D.
Email:
Principal Investigator
Start date:
November 1, 2022
Completion date:
November 1, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115772
https://www.mayo.edu/research/clinical-trials
