临床试验/NCT02804100

NCT02804100Unknown不适用

A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment

Wenzhou Medical University1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2016年5月最近更新: 2016年11月1日

适应症

试验速览

阶段: 不适用
发起方: Wenzhou Medical University
入组人数: 200
试验地点: 1
主要终点: dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.

研究设计

研究类型: Observational
观察模型: Case Only
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

•Provision of informed consent
•Histologically confirmed stage IIIB/IV NSCLC.
•Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
•Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

排除标准

•Histologically confirmed small cell lung cancer or other metastatic tumors
•Patient had received prior chemotherapy or EGFR-TKIs treatment
•Patients who harbor Exon20 T790M mutation

结局指标

主要结局

dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方

Wenzhou Medical University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Chunming Ding

Professor

Wenzhou Medical University

研究点 (1)

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