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NCT Number: 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

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

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Key information

Conditions

Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

55 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional Study

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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