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

What this trial studies

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

Conditions in scope

• Endometrial Carcinoma

Interventions

• Non-Interventional Study (Other) — Non-Interventional Study

Who can join

Women only · Ages 55 Years and up

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2024-03-27
• Primary completion: 2027-06-30
• Last update posted: 2025-07-18
• First posted: 2024-04-15

Sponsor & contact

Lead sponsor: Mayo Clinic (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.