Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .
详细描述
Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
- •Age ≥ 18 years
- •newly diagnosed patients have not received TKI and chemotherapy
- •patients who are drug-resistant have not received next-generation TKI
排除标准
- •patients who have more than one type of carcinoma
- •patients who reject to sign the informed consent from
- •Inclusion Criteria:
- •patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
- •patients will have regular follow-up in Chinese people liberation army general hospital every month.
- •Exclusion Criteria:
- •patients who are refused to provide the informed consent from
结局指标
主要结局
concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC
时间窗: 6 months
次要结局
- Overall survival(OS) in patients who had driver mutation and received the molecular target therapy(5 years)
- concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC(6 months)
- changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis(5 years)
- Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy(3 years)
研究者
Chen Liang_An
MD,PHD
Chinese PLA General Hospital