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Completed

NCT Number: NCT02113852

Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients

This is an epidemiological,multicenter study of genomic and expression profiles of patients with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are to be recruited by investigational sites.Approximately 100 of them will be from retrospectively collected samples with detailed clinical and 2-year follow-up information after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will be collected after the patient had provided informed consent.All tissue samples will be analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA sequencing and chromosome copy number variation by SNP array at the designated laboratories.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The 2-year follow-up information of all enrolled patients will be collected every 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of written informed consent.
  • Male or female aged≥18 years.
  • .Histological or cytologically confirmed primary NSCLC，including histological subtypes:adenocarcinoma,squamous cell carcinoma and large cell carcinoma etc.
  • .Provision of surgical specimen and blood sample.The retrospective samples will be collected between 2006and 2012 from the bio-bank.
  • Patients must be willing to provide detailed clinical information (sex,age,geographic place,tumor stage,grade,size,smoking history,treatment history if any and outcome data).
  • Heavy smokers(defined as having smoked 20 pack-years or more).
  • Treatment naive patients:No prior chemotherapy,biological,immunological therapy or radical radiotherapy is permitted.

Exclusion criteria

  • Not applicable

Treatment and study plan

Primary outcomes

  1. whole genome copy number variation in NSCLC patients

    Time frame: 2 years

    To indentify and characterize somatic mutations in coding region (exome) in NSCLC patients through next generation sequencing of the tumor and blood samples.To identify and characterize whole genome copy number variation in NSCLC patients by using the standard SNP array(Affymetrix SNP 6.0).To indentify and characterize the transcriptome of tumor versus adjacent normal tissues by using RNA sequencing.

Secondary outcomes

  1. Establish more effective therapy for lung cancer treatment in the future

    Time frame: 2 years

    To identify the changes in molecular pathways and biomarker related to smoking induced lung cancer to help establish more effective therapy for lung cancer treatment in the future.

Sponsors and collaborators

Lead sponsor

Guangdong Association of Clinical Trials

Other

Registry information

Acronym: CHOICE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2014
Registry last updated
Mar 1, 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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