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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT02113852
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Provision of written informed consent.
2. Male or female aged≥18 years.
3. .Histological or cytologically confirmed primary NSCLC，including histological subtypes:adenocarcinoma,squamous cell carcinoma and large cell carcinoma etc.
4. .Provision of surgical specimen and blood sample.The retrospective samples will be collected between 2006and 2012 from the bio-bank.
5. 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).
6. Heavy smokers(defined as having smoked 20 pack-years or more).
7. Treatment naive patients:No prior chemotherapy,biological,immunological therapy or radical radiotherapy is permitted.

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
whole genome copy number variation in NSCLC patients	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 Outcome Measures

Name	Time	Method
Establish more effective therapy for lung cancer treatment in the future	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.