Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416726
• Other study ID #: SHCHE201501
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: January 5, 2017
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Many gene mutations have been detected in lung cancer, which might differ between the primary tumor and the metastases in a same patient. One may cause by the heterogenicity of the tumor, another may cause by the sensitivity of the detection technique. So we determine to use NGS, which is a more sensitive technique, to detect the different gene mutations among the primary tumor, metastatic LN and peripheral blood in advanced nonsquamous NSCLC.

The study was designed as a prospective and single center study. Thirty five patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the primary tumor and metastatic lymph nodes will be obtained by interventional pulmonology technology. And about 10ml peripheral blood will be collected at the same time. The tissue will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, the rest tissue will be extracted with DNA and performed NGS for the qualified DNA sample using Illumina Nextseq500 sequencer.The matched peripheral blood will also be extract with DNA and performed NGS using Illumina Nextseq500 sequencer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Nextseq500 sequencer
The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

References & Publications (6)

Gomez-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. — View Citation

Masago 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. — View Citation

Metzker ML. Sequencing technologies - the next generation. Nat Rev Genet. 2010 Jan;11(1):31-46. doi: 10.1038/nrg2626. Epub 2009 Dec 8. Review. — View Citation

Park S, Holmes-Tisch AJ, Cho EY, Shim YM, Kim J, Kim HS, Lee J, Park YH, Ahn JS, Park K, Jänne 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. — View Citation

Sherwood 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;34:92. doi: 10.1186/s13046-015-0207-9. Review. — View Citation

Wang 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene mutations in matched samples	Gene mutations in primary tumor, matched metastatic LN and peripheral blood samples will be tested using NGS technique.	Up to one and a half years