Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients With Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing
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 suspicious of early-stage lung cancer.
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
- •Inclusion Criteria:
- •Age ≥ 20 years
- •Obtained written informed consent
- •Subjects suspected of having resectable lung cancer on computed tomography
- •Subjects without contraindication to brochoscopy
- •Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using 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
研究组 & 干预措施
Ultrathin bronchoscopy with intratumoral washing
Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing.
干预措施: Ultarthin bronchoscopy with intratumoral washing (Diagnostic Test)
结局指标
主要结局
The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing
时间窗: through study completion, an average of 1 year
Diagnostic accuracy is defined as the number of true positive and true negative genetic alterations detected by Next Generation Sequencing, divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy.
次要结局
- Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue(through study completion, an average of 1 year)
- Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid(through study completion, an average of 1 year)
- Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue(through study completion, an average of 1 year)
- Turn-around time(through study completion, an average of 1 year)
- Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue(through study completion, an average of 1 year)