NCT01820884进行中（未招募）不适用
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial
Ding Ma3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage: ⅠA, endometrial carcinoma;
- •Female, Chinese women;
- •premenopausal women；
- •≤ 50 years old;
- •Pathological diagnosis by curettage/hysteroscopy : G1
- •No prior treatment;
- •Provide written informed consent.
排除标准
- •The suspicious metastasis of ovarian;
- •Family history of ovarian cancer;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials;
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3-year DFS
次要结局
- Clinical gynecologic endocrine function(1-year period)
- Quality of Life(3-year period)
- Overall Survival (OS)(3-year OS)
研究者
Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Huazhong University of Science and Technology
研究点 (3)
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