Acceptability of Testing DNA Markers in Vaginal Fluid for the Detection of Endometrial Cancer

July 7, 2026 updated by: Shariska Harrington, Mayo Clinic
This study evaluates how women feel about using DNA from a vaginal fluid collection for early detection of endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kelly Gunderson
  • Phone Number: 507-422-1892

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
        • Contact:
          • Kelly Gunderson
          • Phone Number: 507-422-1892
        • Principal Investigator:
          • Shariska Harrington, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Self-identified Black females 45 years or older with an intact uterus recruited through Mayo Clinic in Rochester

Description

Inclusion Criteria:

  • Self-identified Black individuals ≥ 45 years with an intact uterus
  • Assigned female sex at birth
  • Experience with abnormal uterine or post-menopausal bleeding (defined as vaginal bleeding between periods, heavy vaginal bleeding, vaginal bleeding after menopause, and/or red, brown, or pink colored vaginal discharge after menopause)
  • Willing to participate in a 45-minute virtual interview

Exclusion Criteria:

  • Previous or current diagnosis of endometrial cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Participants complete a semi-structured interview on study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of vaginal fluid collection for a DNA-based early detection endometrial cancer test
Time Frame: Baseline (30-minute virtual interview)
Information collected during a 30-minute virtual interview using mostly open-ended questions. The interviews will be transcribed and reviewed by the study team to identity themes and create coding categories. Coding categories will be used to organize the data into subthemes. Results will be reported in aggregate. Aggregate results will be disseminated to participants if they elect to receive them.
Baseline (30-minute virtual interview)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Shariska Harrington, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2026

Primary Completion (Estimated)

June 10, 2027

Study Completion (Estimated)

June 10, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-011120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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