跳至主要内容
临床试验/NCT02169349
NCT02169349已完成不适用

Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6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
100
试验地点
1
主要终点
Mutation profiling of circulating tumor DNA from plasma samples.

研究概览

简要总结

The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).

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

入选标准

  • Signed written informed consent
  • Male or female aged >= 18 years
  • Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed

排除标准

  • Tissue and plasma samples can not be provided for mutation analysis
  • Unwilling or unable to provide informed consent
  • Any serious medical condition that would interfere with the subject's safety

结局指标

主要结局

Mutation profiling of circulating tumor DNA from plasma samples.

时间窗: 1 year

To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.

次要结局

  • Quantity of circulating tumor DNA in serially collected plasma specimens.(1 year)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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