Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Concordance rate
研究概览
简要总结
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).
详细描述
This study is comprised of two cohorts as below:
Cohort A: inoperable, untreated, non-small cell lung cancer patients
Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures, sampling, and analyses
- •Pathologically confirmed non-small cell lung cancer
- •Male or female, aged at least 20 years
- •Matches one of two criteria :
- •Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy
- •Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent.
排除标准
- •Any concurrent and/or other active malignancy that has required treatment within 3 years
- •Patients with mixed small cell histology
- •Life expectancy less than 3 months
- •Insufficient tissue for NGS test
结局指标
主要结局
Concordance rate
时间窗: an average of one year
Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA
次要结局
- Frequency of actionable genomic change(an average of one year)
- Overall survival by treatment(an average of one year)
- Overall survival(an average of one year)
研究者
Jong-Seok Lee
Professor
Seoul National University Bundang Hospital