Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The study aims to evaluate the Plasma-SeqSensei™ Solid Cancer IVD Kit NGS diagnostic test (Sysmex) before its introduction into routine diagnostics. This is a test for research of EGFR mutations in cfDNA that needs to be evaluated in a patient population with lung adenocarcinoma already characterized for EGFR mutations by a molecular test of reference. The proposed study does not present any risk to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Males or Females aged at least 18 years;
- •Patients with advanced or metastatic non-small cell lung cancer at diagnosis or progression who have previously had the cobas® EGFR Mutation Test v2 (Roche) performed on a liquid biopsy with a valid result (positive or negative);
- •Availability of 6 mL of plasma.
排除标准
- •Plasma not available in sufficient quantities to perform both tests;
- •Cobas test with invalid result.
研究组 & 干预措施
SeqSensei™ Solid Cancer IVD Kit (Sysmex)
干预措施: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex) (Diagnostic Test)
cobas® EGFR Mutation Test v2 (Roche)
干预措施: cobas® EGFR Mutation Test v2 (Roche) (Diagnostic Test)
结局指标
主要结局
Primary Outcome
时间窗: Through study completion, an average of 1 year
Evaluate the capability of the NGS test Plasma-SeqSensei™ Solid Cancer IVD Kit (Sysmex) in detecting a greater number of EGFR mutations compared to the diagnostic test routine cobas® EGFR Mutation Test v2 (Roche)
次要结局
- Secondary Outcome(Through study completion, an average of 1 year)