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

Status: Enrolling

Conditions: Endometrial Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06365905

23-011680 (Other Identifier)

NCI-2024-02550 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 1 patient group

Observational

Description:

Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.

Treatment:

Other: Non-Interventional Study