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OpenTrials
Completed

NCT Number: NCT02416726

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Gene mutations in matched samples

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jiayuan Sun

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2015
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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