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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06115772
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. To determine the risk of requiring additional procedures or treatments secondary to these diagnoses.

3. To determine the sexual health and well-being among patients and partners with HPV(+)OPSCC.

4. To develop standardized patient education and recommendations for referral and screening for this patient population.

5. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 154 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2027
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Observational 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.	Other: Non-Interventional Study; Non-interventional study

Outcome Measures

Primary Outcome Measures

1. Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC [Baseline (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).

2. Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC [Baseline (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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Kathryn M. Van Abel, M.D., Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06115772
• Other Study ID Numbers: 22-005420; NCI-2023-04392; 22-005420; P30CA015083
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma

Study Results

No Results Posted as of Nov 3, 2023