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

ConditionEndometrial Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age55+

SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnostic tests performed more than 90 days apart

Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)

Trial population

Patients with at least one episode of postmenopausal bleeding.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Non-Interventional Study
Other intervention
Non-Interventional Study

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Observational1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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