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临床试验/NCT02416726
NCT02416726已完成不适用

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

Jiayuan Sun1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Gene mutations in matched samples

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Gene mutations in matched samples

时间窗: Up to one and a half years

Gene mutations in primary tumor, matched metastatic LN and peripheral blood samples will be tested using NGS technique.

次要结局

未报告次要终点

研究者

发起方
Jiayuan Sun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiayuan Sun

Director, Endoscope Department, Shanghai Chest Hospital

Shanghai Chest Hospital

研究点 (1)

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