Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years.
- •Histologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-
- •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.
排除标准
- •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.
结局指标
主要结局
Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment
时间窗: 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.
次要结局
- Comparison of ultrasound and MRI findings(Baseline)
- Endometrial ultrasound changes during medical treatment(Baseline, 6 months, and 12 months post-treatment initiation.)
- Ultrasound predictors of treatment response(Baseline and 6 months post-treatment.)
- Endometrial ultrasound characteristics and reproductive success(Baseline and 12 months post-treatment)
- Correlation between ultrasound and molecular profiling(Baseline)