Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- chemotherapy cycles
研究概览
简要总结
The purpose of present study is to provide clinical evidences for the appropriate management of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). Lung nodule <1.0cm will directly treated as group C
详细描述
The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical characteristics of patients were compared, especially chemotherapy cycles to achieve hCG normalization and failure to first-line chemotherapy.
Lung nodule <1.0cm will directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)
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
- — 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible patients have to meet all of the following criteria:
- •Pathologically confirmed HM.
- •The lung nodules are detected by lung CT and metastatic lesions could not be excluded (before or after the suction dilation and curettage).
- •The hCG level does not meet FIGO diagnostic criteria (2018) of GTN.
- •The patients are willing to compliant with the study protocol and be followed up at regular intervals.
- •The patients agree to sign an informed consent form.
排除标准
- •The patients with a previous history of lung nodules.
- •The imaging impression of lung nodules suggested definitely caused by other diseases, such as tuberculosis, pneumonia, etc.
- •The patients have undergone prophylactic hysterectomy or chemotherapy.
- •Pathologically confirmed gestational trophoblastic neoplasia before and at enrollment.
- •Patients have immunosuppressive diseases or take immunosuppressants.
- •Patients are participating in other clinical trials at same time.
- •Patients were unable or unwilling to provide written informed consent.
研究组 & 干预措施
A:chemotherapy immediately
Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
干预措施: chemotherapy (Drug)
B:follow up
B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.
B2: follow up until hCG level declined to normal spontaneously.
干预措施: Follow up (Other)
B:follow up
B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.
B2: follow up until hCG level declined to normal spontaneously.
干预措施: chemotherapy (Drug)
C: lung nodule diameter <1.0 cm
C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.
干预措施: Follow up (Other)
C: lung nodule diameter <1.0 cm
C1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy. C2: follow up until hCG level declined to normal spontaneously.
干预措施: chemotherapy (Drug)
结局指标
主要结局
chemotherapy cycles
时间窗: 120 months
the efficacy and number of treatment cycles in the chemotherapy group
hCG declined to normal spontaneously of group B
时间窗: 120 months
the spontaneous regression rate in Group B
次要结局
- follow up of group A , B and C(240 months)
- lung nodules(240 months)
研究者
Lixiao
Professor
Women's Hospital School Of Medicine Zhejiang University