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NCT06365905Recruiting

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

Mayo Clinic

Start Date

3/27/2024

Completion Date

6/30/2027

Summary

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

Detailed Description

PRIMARY OBJECTIVE: I. Prospective validation of an artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) to identify patients with premalignant/malignant in a population of women with postmenopausal bleeding (PMB). OUTLINE: This is an observational study. Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.

Eligibility Criteria

Age Range: 55 years to No maximum

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)

Interventions

OTHER

Non-Interventional Study

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Conditions

Endometrial Carcinoma

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona 85259

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224-9980

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States