Department of Obstetrics & Gynecology ，Peking University People's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- sensitivity
研究概览
简要总结
To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation
详细描述
After diagnosed of early endometrial carcinoma (EEC) or atypical endometrial hyperplasia (AEH) by hysteroscopy, patients meet the study criteria will be enrolled.
Patients will receive MPA (Medroxyprogesterone acetate) 250-500mg or MA (megestrol acetate) 160-320mg by mouth daily. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Hysteroscopy will continue until pathology confirms complete response. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR or SD. Patients with PD will be recommended for hysterectomy.
During each hysteroscopy, the intraoperative residual tissues were sent to the laboratory of College of Future Science and Technology of Peking University for culture as Patient-derived tumor-like cell clusters (PTC), and the content of lipids (lipid droplet size and cholesterol content) was measured by stimulated Raman scattering imaging and recorded. After collecting the data of 148 cases, the prediction model was constructed. Then the model is validated in the validation set composed of 96 new cases. In order to determine the accuracy and sensitivity of the model.
If a patient has achieved a pathological complete response and a high lipid content is detected in the tissue by stimulated Raman scattering imaging, we will follow up for subsequent recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 17 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed pathological diagnosis based upon hysteroscopy: atypical endometrial hyperplasia or histologically prove well-differentiated EEC G1 without myometrial invasion
- •No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- •Have a desire for remaining reproductive function or uterus
- •Good compliance with adjunctive treatment and follow-up
排除标准
- •Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- •Pregnancy or potential pregnancy
- •Confirmed diagnosis of any cancer in reproductive system
- •Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- •Hypersensitivity or contradiction for using MPA or MA
- •With other factors of reproductive dysfunction;
- •Strong request for uterine removal or other conservative treatment
结局指标
主要结局
sensitivity
时间窗: 7 months
The sensitivity of the prediction model
accuracy
时间窗: 7 months
The accuracy of the prediction model
次要结局
- false-positive rate(7 months)
- false-negative rate(7 months)
研究者
Wang Jianliu
Professor, Doctoral supervisor, Chief physician, Vice President
Peking University People's Hospital