Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
研究概览
简要总结
This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years and under 75 years
- •Histologically and cytologically proven non-small Cell Lung Cancer
- •Clinical stages Ⅲ ~ Ⅳ
- •Not receive any anti-tumor treatment
- •Eastern cooperative oncology group performance status (ECOG PS) =1~2
- •Estimated survival time more than 3 months
- •EGFR-TKI treatment for first-line or second-line
- •Voluntary to participate in this clinical trial and sign the consent form
排除标准
- •Patients have received EGFR-TKI therapy before the study
- •With other malignancy history in the recent 5 years before the study
- •Pregnancy or breast feeding phase
- •Inadequate samples for testing
- •Follow-up compliance is poor
结局指标
主要结局
EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
时间窗: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years
In order to monitor the change of plasma EGFR mutation copy number.
EGFR Mutation Detection of FFPE and plasma samples
时间窗: baseline
To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.
次要结局
未报告次要终点