Menu
Recruiting NCT06365905

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

— Observational Endometrial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Endometrial Carcinoma. Basic parameters: from 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Other Non-Interventional Study
    Non-Interventional Study

Primary outcome measures

  • Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) [Time frame: Baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06365905 · 23-011680 · NCI-2024-02550 · 23-011680

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗