NCT02623257已完成不适用
A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer
First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 1,055 人开始时间: 2016年1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
- 1,055
- 试验地点
- 1
- 主要终点
- Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
研究概览
简要总结
The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.
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
- •Histologically confirmed stage IIIB/IV NSCLC;
- •Patient had received ≤ 1 prior systemic chemotherapy regimens;
- •Provision of blood (plasma) sample for ctDNA testing;
- •Patient must be able to comply with the protocol;
排除标准
- •Prior received ≥2 systemic chemotherapy regimens;
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
- •Histologically confirmed small cell lung cancer or other metastatic tumors;
- •Patient with no histologic or cytological diagnosis;
结局指标
主要结局
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
时间窗: up to 2 years
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)
次要结局
- Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics(up to 2 years)
- Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay(up to 2 years)
- Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay(up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)Non Small Cell Lung CancerNCT01081496AstraZeneca1,000
Unknown
不适用
EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI TreatmentNon-small Cell Lung CancerNCT02644889GenoSaber100
已完成
不适用
Exploratory study on detecting EGFR mutation including T790M with blood samples from patients with advanced non-small cell lung cancer after EGFR-TKI failureAdvanced non-small cell lung cancer with EGFR mutationJPRN-UMIN000021860Shizuoka cancer center120
已完成
不适用
Monitoring study of genomic mutations in patients with EGFR mutation or ALK translocation using plasma DNAnon-small-cell lung cancerJPRN-UMIN000035628Wakayama Medical University100
Unknown
不适用
A Retrospective Molecular Epidemiology Study in Singapore Patients With Advanced Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation StatusNSCLCNCT01100827National University Hospital, Singapore