A Prospective Study to Evaluate the Consistency of Next-G... | NCT03546452

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

NCT03546452

Sponsor

Shanghai Chest Hospital

Status

Unknown status

Last Update Posted

Jun 7, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Malignant Hydrothorax
NSCLC

Interventions

in vitro NGS-panel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2018Actual

Primary Completion Date

Sep 30, 2018Estimated

Completion Date

May 1, 2019Estimated

First Submitted Date

May 22, 2018

First Submission Date that Met QC Criteria

Jun 2, 2018

First Posted Date

Jun 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2018

Last Update Posted Date

Jun 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lu Shun, Shanghai Chest Hospital, Shanghai Chest HospitalPrincipal Investigator

Lead Sponsor

Shanghai Chest HospitalOTHER

Collaborators

Name	Class
Sinotech Genomics Co., Ltd	UNKNOWN
Amoy Diagnostics	INDUSTRY
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.	INDUSTRY
Geneplus-Beijing Co. Ltd.

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
in vitro NGS-panel	Diagnostic Test	cell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel	malignant NSCLC hydrothorax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate consistency of TMB value of different NGS-Panel	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients in shanghai chest hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shun lu, Prof.	Contact	021-2220000		shun_lu@hotmail.com
yongfeng yu, Prof.	Contact	18017321559		yuyongfeng212@126.com

Overall Officials

Name	Affiliation	Role
shun lu, Prof.	Shanghai Chest Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shangha Chest Hospital	Recruiting	Shanghai	Shanghai Municipality	200030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided