Preoperative Risk Stratification in Endometrial Cancer Using Expert Ultrasound and Molecular Classification for Tailoring Lymph Node Staging: Multicentric Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The accuracy of preoperative risk stratification
研究概览
简要总结
The goal of this observational study is to evaluaty the accuracy of current risk stratification of patients with endometrial cancer and to redefine lymph node staging recommendations based on real-world clinical data. The main question it aims to answer is:
Is there any group of patients who doesn't need lymph node staging for proper indication of adjuvant treatment? Participants are note taking any intervention. They are treated according to current standard of care and followed 3-years after primary surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years with newly diagnosed endometrial cancer (any histology)
- •Undergoing primary surgical management
- •Preoperative expert ultrasound, CT scan (could be waived in low risk cases)
- •Preoperatively early-stage (stage I-II) of EC
- •SLN mapping attempted intraoperatively
- •FFPE tumor tissue available for molecular and IHC testing from biopsy
- •Signed informed consent with the participation in the study
排除标准
- •Neoadjuvant treatment
- •Recurrent or metastatic disease at diagnosis
- •Inadequate imaging or tissue samples
- •Cancer synchronous duplicity
- •Prior oncological treatment within the last five years
结局指标
主要结局
The accuracy of preoperative risk stratification
时间窗: From enrollment to the first follow-up visit at 4 weeks after surgery.
Determination of specific groups for whom: 1) lymph node staging is crucial for changing risk category and adjuvant treatment decisions, and 2) lymph node staging could be safely omitted
时间窗: From enrollment to the first follow-up visit at 4 weeks after surgery.
次要结局
未报告次要终点