Clinical trial · Observational
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
NCT06365905CI-TRIAL-00114232recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.