Recruiting

AI-Based ClassifierNon-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding

Sponsor:

Mayo Clinic

Code:

NCT06365905

Conditions

Endometrial Carcinoma

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.

Conditions

Endometrial Carcinoma

Study ID

NCT06365905

Start date

Mar 27, 2024

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age ≥ 55 years
At least one episode of postmenopausal bleeding (PMB)
Endometrial biopsy available from at Mayo Clinic (MN, AZ, FL), Mayo Clinic Health System (MCHS), or an external institution
Acceptance to participate in the study

Exclusion Criteria:

Diagnostic tests performed more than 90 days apart
Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Primary outcome measure

Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Kristina A. Butler, MD, MS

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Christopher C. DeStephano, MD, MPH

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Gretchen E. Glaser, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-10.