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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03546452
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 7, 2018
Sinotech Genomics Co., Ltd
Amoy Diagnostics Co., LTD
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
Geneplus-Beijing Co. Ltd.
Berry Genomics Co., Ltd.
Information provided by (Responsible Party):
Lu Shun, 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.

Condition or disease Intervention/treatment
Malignant Hydrothorax NSCLC Diagnostic Test: in vitro NGS-panel

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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
cell block obtain from malignant NSCLC hydrothorax

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients in shanghai chest hospital

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03546452

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Contact: shun lu, Prof. 021-2220000
Contact: yongfeng yu, Prof. 18017321559

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China, Shanghai
Shangha Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: yongfeng yu    18017321559   
Sponsors and Collaborators
Shanghai Chest Hospital
Sinotech Genomics Co., Ltd
Amoy Diagnostics Co., LTD
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
Geneplus-Beijing Co. Ltd.
Berry Genomics Co., Ltd.
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Principal Investigator: shun lu, Prof. Shanghai Chest Hospital

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Responsible Party: Lu Shun, Shanghai Chest Hospital Identifier: NCT03546452     History of Changes
Other Study ID Numbers: shanghai Chest 0014
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lu Shun, Shanghai Chest Hospital:
malignant hydrothorax
prospective study

Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases