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

NCT02416726 | Completed DMC

• 1 other identifier: SHCHE201501
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Cancer

Keywords

Gene testing; Next-generation sequecing; Primary tumor; Metastatic lymph node; Peripheral blood

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Peripheral blood

EXPERIMENTAL

The peripheral blood sample will be extrated with DNA and performed NGS using Illumina Nextseq500 sequencer.

Device: Nextseq500 sequencer

Primary tumor

EXPERIMENTAL

The gene testing of the primary tumor tissue diagnosed with nonsquamous NSCLC will be performed with NGS technique using Illumina Nextseq500 sequencer.

Device: Nextseq500 sequencer

Metastatic lymph node

EXPERIMENTAL

The gene testing of the metastatic lymph node tissue diagnosed with nonsquamous NSCLC will be performed with NGS technique using Illumina Nextseq500 sequencer.

Device: Nextseq500 sequencer

Interventions

Nextseq500 sequencer DEVICE

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

Metastatic lymph node; Peripheral blood; Primary tumor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially,
• There exist at least one primary tumor and at least one enlarged LN which can be biopsied by minimally invasive techniques.

You may not qualify if:

• The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data.
• Surgery was considered to be the primary treatment.
• Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (6)

• 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.

  PMID: 25445553 BACKGROUND

• 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(1):92. doi: 10.1186/s13046-015-0207-9.

  PMID: 26338018 BACKGROUND

• 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.

  PMID: 26572169 BACKGROUND

• Park 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 BACKGROUND

• 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.

  PMID: 19687761 BACKGROUND

• Metzker 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 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, MD,PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Endoscope Department, Shanghai Chest Hospital

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 15, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)