A Prospective Study to Evaluate the Results of Different NGS- Panels in Mutation Detection and Tumor Mutation Burden(TMB) Calculation by Using Malignant Hydrothorax From NSCLC
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate consistency of TMB value of different NGS-Panel
研究概览
简要总结
A prospective study to evaluate consistency of different NGS-panel. Cell free DNA is purified from each malignant hydrothorax from NSCLC .Different NGS-panels are applied to perform in vitro diagnosis to detect Single Nucleotide Variants(SNV) and to calculate TMB value in these DNA samples.Consistency of enrolled NGS-panels are then evaluated by statistical analysis.
详细描述
- Chest Hospital in accordance with the clinical requirements of the treatment required to extract ML hydrothorax sent to hospital pathology department for exfoliated Cell diagnosis and production of cell wax block, while the additional responsibility for the extraction of hydrothorax 500ml, and collect 10ml venous blood sample, Venous blood samples are stored in either the A cell-free DNA Blood collection Tube (STRECK tube) or the ethylenediaminetetraacetic acid(EDTA) anticoagulant tube.
- Amoy Diagnostics Co., Ltd. (AmoyDx) is responsible for plasma separation after sampling 2 hours, plasma is frozen by the chest Hospital, AmoyDx completes the purification of peripheral blood cells genomic DNA , and which is divided into 6 parts ,5 of which are send to in vitro diagnostic products (IVD) enterprises to perform NGS-Panel detection.
- 100ml hydrothorax is send to each IVD enterprise.
- Each IVD enterprise carries on the hydrothorax cell free DNA and peripheral blood cell genomic DNA NGS-Panel detection according to their own protocol.
- Each IVD enterprise will complete the test within 7-10 working days and fill out the results in accordance with the report template provided by this research project (provided by Guangzhou Burning Rock Medical Examination Institute Co., Ltd.) and submit to sponsor by email.
- Sponsor would use whole exon panel (WES) to obtain an TMB value if needed.
- Employ four-grid analysis to evaluate positive compliance rate, negative compliance rate, total compliance rate of all submitted data.
- Employ kappa test to evaluate the consistency of each two detections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced malignant lung cancer, with treatment of pleural effusion, hydrothorax volume not less than 800ml
排除标准
- •The sample size is not sufficient to detect.
- •There are not enough tumor cells in the tissue section to be evaluated through the pathology department of the chest Hospital.
结局指标
主要结局
Evaluate consistency of TMB value of different NGS-Panel
时间窗: 5 months
All DNA samples were tested to calculate TMB value by all enrolled NGS-panel (include WES if necessary), each sample is then to be marked as TMB high, TMB median or TMB low according to the cutoff value identified by different IVD enterprises. Employ Cohen's kappa test to calculate the kappa value to measures inter-rater agreement for categorical result.
次要结局
未报告次要终点
研究者
Lu Shun
Shanghai Chest Hospital
Shanghai Chest Hospital