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

Guangdong Association of Clinical Trials

Status: Completed

Conditions: Non Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02113852

CTONG 1308

Details and patient eligibility

About

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.

Full description

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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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