NCT07527143

Brief Summary

This study evaluates how women feel about using DNA from a vaginal fluid collection for early detection of endometrial cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

April 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability of vaginal fluid collection for a DNA-based early detection endometrial cancer test

    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)

Study Arms (1)

Observational

Participants complete a semi-structured interview on study.

Other: Non-Interventional Study

Interventions

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
Observational

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Previous or current diagnosis of endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Shariska Harrington, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

Kelly Gunderson

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

June 10, 2027

Study Completion (Estimated)

June 10, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations