a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- susceptibility gene site of small cell lung cancer
研究概览
简要总结
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- •Life expectancy > 10 months
- •Karnofsky Performance Status ≥ 70
- •Diagnosis of histological or cytologically confirmed SCLC,
- •Age ≥ 18 years
- •Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
排除标准
- •Poor compliance, reluctant to undergo research medication, or follow-up.
- •Tumor inaccessible for biopsy
- •It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
- •It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
结局指标
主要结局
susceptibility gene site of small cell lung cancer
时间窗: 01.11.2017-31.05.2018
searching susceptibility gene site of small cell lung cancer according to germline mutation data
次要结局
- consistency of ctDNA and tDNA sequencing results in patients with SCLC(01.11.2017-31.05.2018)