Clinical trial · Observational
A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Hydrothorax | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| in vitro NGS-panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- malignant NSCLC hydrothorax
- description
- cell free DNA ,which is purified from malignant NSCLC hydrothorax, tested by in vitro NGS-panel
- interventionNames
- Diagnostic Test: in vitro NGS-panel
Primary outcomes (1)
- measure
- Evaluate consistency of TMB value of different NGS-Panel
- timeFrame
- 5 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available