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 — OTHERNon-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: ObservationalPatients 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
- Clinical Trials Referral Office855-776-0015
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Kristina A. Butler, MD, MS (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Christopher C. DeStephano, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Gretchen E. Glaser, MD (PRINCIPAL_INVESTIGATOR) |
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