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
- 否
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
研究点 (1)
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