NCT03546452

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

May 22, 2018

Last Update Submit

June 5, 2018

Conditions

Malignant HydrothoraxNSCLC

Keywords

NSCLCmalignant hydrothoraxprospective study

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

in vitro NGS-panelDIAGNOSTIC_TEST

cell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel

malignant NSCLC hydrothorax

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients in shanghai chest hospital

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shangha Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cell block obtain from malignant NSCLC hydrothorax

Study Officials

  • shun lu, Prof.

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shun lu, Prof.

CONTACT

021-2220000shun_lu@hotmail.com

yongfeng yu, Prof.

CONTACT

18017321559yuyongfeng212@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai Chest Hospital

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 6, 2018

Study Start

May 18, 2018

Primary Completion

September 30, 2018

Study Completion

May 1, 2019

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

CN(1)