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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Nextseq500 sequencer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral blood<br>The peripheral blood sample will be extrated with DNA and performed NGS using Illumina Nextseq500 sequencer. | Device: Nextseq500 sequencer<br>* The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.<br>|
| Experimental: Primary tumor<br>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<br>* The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.<br>|
| Experimental: Metastatic lymph node<br>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<br>* The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gene testing, Next-generation sequecing, Primary tumor, Metastatic lymph node, Peripheral blood