Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06115772

Conditions

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

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).

Conditions

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Study ID

NCT06115772

Start date

Nov 1, 2022

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

154 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Kathryn M. Van Abel, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.