Clinical trial · Interventional
Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS
Comparison of Gene Mutations Among the Primary Tumor, Matched Metastatic Lymph Node and Peripheral Blood in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing
NCT02416726CI-TRIAL-00025380completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The objective of the study was to compare the gene mutation status among the primary tumor, matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small cell lung cancer (NSCLC) using next-generation sequencing (NGS).
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nextseq500 sequencer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Peripheral blood
- description
- The peripheral blood sample will be extrated with DNA and performed NGS using Illumina Nextseq500 sequencer.
- interventionNames
- Device: Nextseq500 sequencer
- type
- EXPERIMENTAL
- label
- Primary tumor
- description
- The gene testing of the primary tumor tissue diagnosed with nonsquamous NSCLC will be performed with NGS technique using Illumina Nextseq500 sequencer.
- interventionNames
- Device: Nextseq500 sequencer
- type
- EXPERIMENTAL
- label
- Metastatic lymph node
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study. 2. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially, 3. There exist at least one primary tumor and at least one enlarged LN which can be biopsied by minimally invasive techniques. Exclusion Criteria: 1. The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data. 2. Surgery was considered to be the primary treatment. 3. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.
References
Publications (6)
- BACKGROUNDWang S, Wang Z. Meta-analysis of epidermal growth factor receptor and KRAS gene status between primary and corresponding metastatic tumours of non-small cell lung cancer. Clin Oncol (R Coll Radiol). 2015 Jan;27(1):30-9. doi: 10.1016/j.clon.2014.09.014. Epub 2014 Oct 14. PMID 25445553
- BACKGROUNDSherwood J, Dearden S, Ratcliffe M, Walker J. Mutation status concordance between primary lesions and metastatic sites of advanced non-small-cell lung cancer and the impact of mutation testing methodologies: a literature review. J Exp Clin Cancer Res. 2015 Sep 4;34(1):92. doi: 10.1186/s13046-015-0207-9. PMID 26338018
- BACKGROUNDMasago K, Fujita S, Muraki M, Hata A, Okuda C, Otsuka K, Kaji R, Takeshita J, Kato R, Katakami N, Hirata Y. Next-generation sequencing of tyrosine kinase inhibitor-resistant non-small-cell lung cancers in patients harboring epidermal growth factor-activating mutations. BMC Cancer. 2015 Nov 16;15:908. doi: 10.1186/s12885-015-1925-2. PMID 26572169
- BACKGROUNDPark S, Holmes-Tisch AJ, Cho EY, Shim YM, Kim J, Kim HS, Lee J, Park YH, Ahn JS, Park K, Janne PA, Ahn MJ. Discordance of molecular biomarkers associated with epidermal growth factor receptor pathway between primary tumors and lymph node metastasis in non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):809-15. doi: 10.1097/JTO.0b013e3181a94af4. PMID 19487967
- BACKGROUNDGomez-Roca C, Raynaud CM, Penault-Llorca F, Mercier O, Commo F, Morat L, Sabatier L, Dartevelle P, Taranchon E, Besse B, Validire P, Italiano A, Soria JC. Differential expression of biomarkers in primary non-small cell lung cancer and metastatic sites. J Thorac Oncol. 2009 Oct;4(10):1212-20. doi: 10.1097/JTO.0b013e3181b44321. PMID 19687761
- BACKGROUNDMetzker ML. Sequencing technologies - the next generation. Nat Rev Genet. 2010 Jan;11(1):31-46. doi: 10.1038/nrg2626. Epub 2009 Dec 8. PMID 19997069