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NCT06365905 Clinical Trial

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

Endometrial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06365905
Other study ID # 23-011680
Secondary ID NCI-2024-0255023
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 30, 2027

Study information
Verified date April 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender Female
Age group 55 Years and older
Eligibility Inclusion Criteria: - Age = 55 years - At least one episode of PMB - Endometrial biopsy to be performed at Mayo Clinic (MN, AZ, FL) - 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. Baseline
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