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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06365905
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-Interventional Study

Study Details

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

Key Dates

Start date
Mar 27, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
855-776-0015
Kristina A. Butler, MD, MS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
855-776-0015
Christopher C. DeStephano, MD, MPH (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Gretchen E. Glaser, MD (PRINCIPAL_INVESTIGATOR)

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