NCT07028242Not yet recruiting
Ultrasound and Histology in AEH and Early EEC Treated Conservatively
Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
Source: ClinicalTrials.gov · Last updated 19 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- 11 Jun 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometrial cancer
- NCT number
- NCT07028242
What you commit to
- Study type: Observational
- Planned participants: 50
- From 11 Jun 2025 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous hysterectomy or non-conservative surgical treatment.
Other illness
- Contraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies).
Other
- Women under 18 or over 45 years.
- Presence of myometrial invasion on MRI or histological analysis.
- Histological diagnosis of serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma.
- Pregnancy at the time of enrollment.
- Lack of adequate imaging for ultrasound-based assessment.
Who the study is looking for
- Women aged 18-45 years.
- Histologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.
- Candidates for fertility-sparing treatment (hysteroscopic resection and/or progestin therapy).
- No prior history of invasive endometrial carcinoma.
- Adequate endometrial visualization via transvaginal ultrasound (TVUS) and/or MRI.
- Signed informed consent for study participation.
Age in the registry: 18 years to 45 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.