A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC
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|ClinicalTrials.gov Identifier: NCT03546452|
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment|
|Malignant Hydrothorax NSCLC||Diagnostic Test: in vitro NGS-panel|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||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|
|Actual Study Start Date :||May 18, 2018|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||May 1, 2019|
malignant NSCLC hydrothorax
cell free DNA ,which is purified from malignant NSCLC hydrothorax, tested by in vitro NGS-panel
Diagnostic Test: in vitro NGS-panel
cell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel
- Evaluate consistency of TMB value of different NGS-Panel [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546452
|Contact: shun lu, Prof.||email@example.com|
|Contact: yongfeng yu, Prof.||firstname.lastname@example.org|
|Shangha Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: yongfeng yu 18017321559 email@example.com|
|Principal Investigator:||shun lu, Prof.||Shanghai Chest Hospital|