NCT04229121Unknown不适用
Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients
Shanghai Pulmonary Hospital, Shanghai, China0 个研究点目标入组 100 人开始时间: 2020年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- The gene mutation coincidence rate between CTCs and tumor tissue sample
研究概览
简要总结
Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation
详细描述
- Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue.
- Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, 18 years of age or older
- •Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy
- •Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital
- •Signed and dated informed consent
排除标准
- •Combine with other tumor type
- •The investigator judges the situation that may affect the clinical search process and results
结局指标
主要结局
The gene mutation coincidence rate between CTCs and tumor tissue sample
时间窗: 6 months
Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample
Driver gene mutation frequency from CTCs of advanced NSCLC patients
时间窗: 6 months
Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation
次要结局
- The gene mutation coincidence rate between CTCs and ctDNA(6 months)
- Driver gene mutation frequency from ctDNA of advanced NSCLC patients(6 months)
研究者
Caicun Zhou
Director Head of Medical Oncology
Shanghai Pulmonary Hospital, Shanghai, China
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