A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC

• Conditions: NSCLC; Malignant Hydrothorax
• Interventions: Diagnostic Test: in vitro NGS-panel

• Registration Number: NCT03546452
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed Description

1. 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.

2. 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.

3. 100ml hydrothorax is send to each IVD enterprise.

4. Each IVD enterprise carries on the hydrothorax cell free DNA and peripheral blood cell genomic DNA NGS-Panel detection according to their own protocol.

5. 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.

6. Sponsor would use whole exon panel (WES) to obtain an TMB value if needed.

7. Employ four-grid analysis to evaluate positive compliance rate, negative compliance rate, total compliance rate of all submitted data.

8. Employ kappa test to evaluate the consistency of each two detections.

Study Timeline

• Study Start: 2018-05-18
• Study First Submitted: 2018-05-22
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-02
• Last Update Submitted: 2018-06-05
• Study First Posted: 2018-06-06
• Last Update Posted: 2018-06-07
• Primary Completion: 2018-09-30
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Advanced malignant lung cancer, with treatment of pleural effusion, hydrothorax volume not less than 800ml

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
malignant NSCLC hydrothorax	in vitro NGS-panel	cell free DNA ,which is purified from malignant NSCLC hydrothorax, tested by in vitro NGS-panel

Primary Outcome Measures

Name	Time	Method
Evaluate consistency of TMB value of different NGS-Panel	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.

Trial Locations

Locations (1)

Shangha Chest Hospital; 🇨🇳 Shanghai, Shanghai, China