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

June 5, 2018 updated by: Lu Shun, Shanghai Chest Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shangha Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients in shanghai chest hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

Geneplus-Beijing Co. Ltd.
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
Sinotech Genomics Co., Ltd
Amoy Diagnostics Co., LTD
Berry Genomics Co., Ltd.

Investigators

  • Principal Investigator: Shun Lu, Prof., Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2018

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 2, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • shanghai Chest 0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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