Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 9
- 主要终点
- To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis
研究概览
简要总结
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
详细描述
This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).
Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Male or female patients aged ≥ 18 years at time of proposal study,
- •Histologically confirmed non-small cell lung carcinoma,
- •No previous treatment for NSCLC,
- •Indication to EGFR status determination following HAS recommendation,
- •Voluntary signed and dated written informed consent prior to any study specific procedure
- •Patients with a social security in compliance with the French Law.
排除标准
- •Treatment for advanced NSCLC started before liquid biopsy sampling.
- •Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
研究组 & 干预措施
All patients
For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing.
As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample.
干预措施: EGFR gene mutation analysis on liquid biopsy (Diagnostic Test)
结局指标
主要结局
To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis
时间窗: within 3 weeks after signature of informed consent
Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure
次要结局
- The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only(within 3 weeks after signature of informed consent)
- The concordance and discordance rates between the two procedures(within 3 weeks after signature of informed consent)
- The detection rate of patients with an EGFR actionable alteration based on tissue analysis only(within 3 weeks after signature of informed consent)
- The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)(within 3 weeks after signature of informed consent)
- Delay to obtain sequencing results(within 3 weeks after signature of informed consent)
- Delay for treatment initiation(within 3 months after signature of informed consent)