Clinical trial · Observational
Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
Tianjin Medical University Cancer Institute and Hospital
- 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)
In recent years, the development of lung cancer has been improved from pathological level to the molecular level. Research showed that there are many gene mutations in non-small cell lung cancer (NSCLC), and some activating mutations have become the hotspots in target therapy area. With the development of targeted drug research, the molecular classification of NSCLC will be more and more important. But a large number of clinical data showed that gene mutation in Chinese NSCLC patients is significantly different from Caucasian population, which suggesting that it is necessary to identify gene mutation profile in Chinese patients with NSCLC. Six hundred NSCLC paraffin tissue samples was collected during operation from Tianjin Cancer hospital in 2009-2012, which including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by next-generation sequencing deep (average 1000X). We will identify gene mutation profile for Chinese lung squamous cell carcinoma and adenocarcinoma patients. The aim is to find related predictor and prognostic factors by analysing the relationship between these gene mutations and clinical characteristics and follow-up treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The correlation between gene mutations and survival
- timeFrame
- December 2017
- description
- The Log-rank test will be used to explore the relationship between the clinical outcomes (DFS and OS, respectively) and gene mutations (present or absent) or each of the clinical features (gender, age, smoking status, TNM staging, histology, tumor location, recurrence, number of lymph node metastasis, tumor size, postoperative adjuvant treatment, DFS and OS). Then a Cox Proportional Hazards model will be constructed to evaluate the effect of multiple variables (genomic and clinical features) on DFS, and OS, respectively. Benjamini-Hochberg false discovery rate (FDR) method is used to adjust the p-value and calculate the statistically differences. All p values were two-sided, and P\<0.05 was assumed to be significant.
Secondary outcomes (1)
- measure
- The correlation between gene mutations and clinical parameters.
- timeFrame
- December 2017
- description
- Correlation between gene mutation data and categorical clinical variables is performed by Fisher's Exact Test.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients enrolled from 2009 to 2012. Histological confirmed NSCLC. Exclusion Criteria: * Received any systemic or local treatment before surgery. Along with other malignant tumors. Lack up intact follow-up information.
References
Publications (0)
Data not yet available