Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set
研究概览
简要总结
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.
详细描述
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 20 years
- •Obtained written informed consent
- •No contraindication to bronchoscopy
- •Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
- •Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing
排除标准
- •Subjects who withdraw informed consent
- •Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement
- •Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
- •Subjects diagnosed with a benign lesion from the lung tissue lesion
结局指标
主要结局
Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set
时间窗: through study completion, an average of 1 year
Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.
次要结局
- The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group(through study completion, an average of 1 year)
- Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set(through study completion, an average of 1 year)
- The incidence of adverse events associated with the bronchial washing procedure(through study completion, an average of 1 year)