Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC), Fertility-Sparing Treatment (FST)
Conditions
Brief 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.
Interventions
PROCEDUREHysteroscopic fertility-sparing surgery and hormonal treatment
Patients undergo hysteroscopic endometrial resection using the Mazzon three-step technique or tissue removal device (TRD), depending on the lesion type. Following surgery, hormonal treatment is administered either via intrauterine device (IUD) or oral progestin. Monitoring includes serial endometrial biopsies and transvaginal ultrasounds at 3, 6, and 12 months.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Inclusion criteria
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.
Exclusion criteria
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. History of previous hysterectomy or non-conservative surgical treatment. Contraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies). Pregnancy at the time of enrollment. Lack of adequate imaging for ultrasound-based assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment | Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy. | Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial ultrasound changes during medical treatment | Baseline, 6 months, and 12 months post-treatment initiation. | Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings. |
| Ultrasound predictors of treatment response | Baseline and 6 months post-treatment. | Comparison of pre-treatment ultrasound features between patients who achieve remission and those with persistent disease after 6 months of therapy. |
| Endometrial ultrasound characteristics and reproductive success | Baseline and 12 months post-treatment | Analysis of pre-treatment ultrasound features in patients who achieve pregnancy versus those with negative reproductive outcomes within 12 months of treatment |
| Correlation between ultrasound and molecular profiling | Baseline | Investigation of potential associations between endometrial ultrasound characteristics and molecular markers of atypical endometrial hyperplasia or endometrial carcinoma |
| Comparison of ultrasound and MRI findings | Baseline | Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions |
Countries
Italy
Contacts
Primary ContactAntonia Carla Testa
Backup ContactFederica Pozzati
Outcome results
None listed