Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- ctDNA mutation profile at baseline
研究概览
简要总结
The purpose of this study is to evaluate the application value of circulating tumor DNA(ctDNA) with efficacy evaluation and prognostic assessment in patients with unresectable SCLC, who were receiving radiotherapy and chemotherapy treatment.
详细描述
- According to each point in time of ctDNA, to analyze the dynamic changes of tumor burden and clonal subtypes which to evaluate the application value of ctDNA in curative efficacy evaluation.
- Compare the two time points before and after radiotherapy and chemotherapy treatment of the cell free DNA (cfDNA) concentration and tumor burden, analysis the correlation between the changes and prognosis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent；
- •Newly diagnosed and histological or cytological confirmed extensive stage small cell lung cancer;
- •All indicators has confirmed and allow to receive radiotherapy and chemotherapy;
- •Follow-up can be carried out and the peripheral blood samples can be collected;
- •Cooperate with the provision of clinical pathological data required by the research.
排除标准
- •Patients have other primary cancers;
- •Patients unable to cooperate with the study for follow-up according to the determined clinical follow-up cycle;
- •Unable to accept the judgment of curative effect evaluation by the designated methods such as CT.
结局指标
主要结局
ctDNA mutation profile at baseline
时间窗: before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
the evolution of ctDNA mutation profile during treatment
时间窗: After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
次要结局
- PFS(From the first line treatment to the time of disease progression (through study completion, an average of 5 months))
研究者
dengpengbo
Attending physician
Xiangya Hospital of Central South University