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: NCT06365905
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-03-27
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.
Non-Interventional Study
Non-Interventional Study
Interventions
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Non-Interventional Study
Non-Interventional Study
Eligibility Criteria
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Inclusion Criteria
* 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
* Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)
55 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Gretchen E Glaser, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-02550
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-011680
Identifier Type: OTHER
Identifier Source: secondary_id
23-011680
Identifier Type: -
Identifier Source: org_study_id
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