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RecruitingObservational

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

NCT ID: NCT06365905Sponsor: Mayo ClinicLast updated: 2026-06-10

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.

Arms & interventions

  • OtherNon-Interventional Study

    Non-Interventional Study

Outcome measures

Primary

  • Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)

    Two static TVUS images (one longitudinal, one transversal) will be independently validated and compared to results of endometrial sampling. Outcomes from these will be compared with predictions made by the AI models for accuracy of assessing premalignant/malignant disease.

    Time frame: Baseline

Eligibility criteria

Sex: FemaleAge: 55 Years and olderHealthy volunteers: No
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 locations (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Recruiting
Clinical Trials Referral Office · Contact
855-776-0015mayocliniccancerstudies@mayo.edu
Kristina A. Butler, MD, MS · Principal Investigator

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Recruiting
Clinical Trials Referral Office · Contact
855-776-0015mayocliniccancerstudies@mayo.edu
Christopher C. DeStephano, MD, MPH · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
855-776-0015mayocliniccancerstudies@mayo.edu
Gretchen E. Glaser, MD · Principal Investigator
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding | Cancerify