NCT01231022已完成不适用
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Protective effection of peripheral hematopoietic stem cell infusion for DILI
研究概览
简要总结
The investigators want to know the role of Peripheral hematopoietic stem cell infusion in avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with Drug Induced Liver Injury.
详细描述
- The researcher investigate the incidence and the cause of Drug Induced Liver Injury in MBC.
- Patients having a complete clinical history and physical examination, receive routine chemotherapy.
- Venous blood Sample(4 ml)is collected before and after each cycle according to the planning time.
- Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is used to detect the protein or gene expression associated with liver function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients should be histologically confirmed with metastatic breast cancer;
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Normal cardiac, hepatic, renal and bone marrow functions;
- •Life expectancy ≥3 months;
排除标准
- •previous history of other malignancies;
- •Central nervous system metastases;
- •Serious or uncontrolled concurrent medical illness.
结局指标
主要结局
Protective effection of peripheral hematopoietic stem cell infusion for DILI
时间窗: 3 months
Patients receiving PHSC infusion after chemotherapy will have lower incidence of DILI. PHSC infusion may improve the liver function.
次要结局
- SNPs genotyping associated with Drug Induced Liver Injury(3 months)
- Change of cytokines(3 months)
研究者
Jun Ren
Director
Peking University Cancer Hospital & Institute
研究点 (1)
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