Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- whole genome copy number variation in NSCLC patients
研究概览
简要总结
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.
详细描述
The 2-year follow-up information of all enrolled patients will be collected every 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not applicable
结局指标
主要结局
whole genome copy number variation in NSCLC patients
时间窗: 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.
次要结局
- Establish more effective therapy for lung cancer treatment in the future(2 years)