NCT01256801已完成不适用
Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年11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
- 36
- 试验地点
- 1
- 主要终点
- immunotherapy response
研究概览
简要总结
The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.
详细描述
- The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
- Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
- The enriched cancer cells are flash frozen and stored at -80℃ until processing.
- The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
- Statistical analysis is performed using unsupervised hierarchical cluster.
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
- 18 Years 至 75 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 and malignant pleural effusion
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •At least one measurable lesion;
- •Normal cardiac, hepatic, renal and bone marrow functions;
- •Life expectancy ≥3 months;
- •Discontinuity of previous chemotherapy for a minimum of 4 weeks.
- •Not receive chemotherapy in pleural cavity
排除标准
- •previous history of other malignancies;
- •previous surgery history on the needle biopsy organ;
- •Serious or uncontrolled concurrent medical illness.
结局指标
主要结局
immunotherapy response
时间窗: 1 month
Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
次要结局
- immunological status(1 month)
研究者
Jun Ren
Director
Peking University Cancer Hospital & Institute
研究点 (1)
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