A Multi-center Cohort Study of Hydatidiform Mole
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Malignant trophoblastic tumor
研究概览
简要总结
The purpose of this study is to construct a cohort for the hydatidiform mole.
详细描述
After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.
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
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with hydatidiform mole (including: complete hydatidiform mole/partial hydatidiform mole; one of twins with hydatidiform mole; ectopic pregnancy hydatidiform mole; macroscopic or microscopic hydatidiform changes indicating early complete or partial hydatidiform mole can not be excluded; atypical placental site nodule) for the first time;
- •Age 13-55 years old;
- •Obtain informed consent and sign an informed consent form
排除标准
- •Patients who are unable to cooperate with the investigation such as mental disorders or cognitive impairment
- •No histopathology diagnosis;
- •Patients with other malignancies
结局指标
主要结局
Malignant trophoblastic tumor
时间窗: 4.5 years
Patients with hydatidiform mole develop malignant trophoblastic tumor. The Federation of International of Gynecologists and Obstetricians criteria for diagnosis of postmolar gestational trophoblastic neoplasia were as follows: (1) when the plateau of human chorionic gonadotrophin (hCG) lasts for four measurements over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; (2) when there is a rise in hCG for three consecutive weekly measurements over at least a period of 2 weeks or more; days 1, 7, 14; (3) If there is a histologic diagnosis of choriocarcinoma.
次要结局
未报告次要终点