Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit
研究概览
简要总结
In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.
- methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
- analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.
详细描述
According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~80 years old
- •Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
- •Did not receive any anti-tumor treatment.
- •Sufficient samples for analysis
排除标准
- •Female patients of childbearing potential who are nursing or are pregnant.
- •Samples are collected after patients receiving anti-tumor treatment.
- •The plasma sample hemolysis.
- •Tumor cells are not found in FFPE samples.
- •Incomplete information of subjects
- •predicting clinical efficacy group:
- •Inclusion Criteria:
- •18~80 years old
- •Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
- •At least one measurable focus
- •With EGFR-TKI treatment
- •Complete follow-up information after EGFR-TKI treatment
- •Sufficient samples for analysis
- •Exclusion Criteria:
- •FFPE samples are collected after EGFR-TKI treatment.
- •Female patients of childbearing potential who are nursing or are pregnant.
- •Tumor cells are not found in FFPE samples.
- •Incomplete information of subjects
结局指标
主要结局
EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit
时间窗: 6 months
Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.
次要结局
未报告次要终点