Clinical Trial

Ultrasound and Histology in AEH and Early EEC Treated Conservatively

Study acronym: ULTRA-SAFE
Not Yet Recruiting
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Record status
This record was last updated June 19, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Ultra-S.A.F.E. is a multicenter, ambispective observational study investigating the ultrasound and histological characteristics of patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2 undergoing fertility-sparing treatment (FST). The study aims to describe pre-treatment ultrasound features, evaluate endometrial modifications during treatment, and assess histological and reproductive outcomes. It includes a prospective cohort (new patients recruited at three gynecologic oncology centers) and a retrospective cohort (patients treated conservatively since January 2023). Approximately 50 patients will be enrolled over 24 months, with clinical, ultrasound, and histological data collected. The ultimate goal is to enhance the diagnostic and monitoring role of transvaginal ultrasound (TVUS) in conservative treatment for fertility preservation.
Trial Details
NCT Number NCT07028242
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC)
Enrollment 50 participants
Start Date 2025-06-11
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-19