This trial has been completed.

Condition non small cell lung cancer
Sponsor Guangdong Association of Clinical Trials
Start date August 2013
End date May 2016
Trial size 250 participants
Trial identifier NCT02113852, CTONG 1308


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model other
Time perspective other

Primary Outcomes

whole genome copy number variation in NSCLC patients
time frame: 2 years

Secondary Outcomes

Establish more effective therapy for lung cancer treatment in the future
time frame: 2 years

Eligibility Criteria

All participants at least 18 years old.

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:

Additional Information

Official title Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients
Principal investigator Yi-Long Wu, MD
Description The 2-year follow-up information of all enrolled patients will be collected every 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Guangdong Association of Clinical Trials.