Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.
详细描述
During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.
In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer 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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects need to sign the informed consent form
- •All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
- •Non-small cell lung cancer have to confirmed pathologically after operation
- •Clinical stage I - IIIA by AJCC 7th staging system
排除标准
- •Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
- •Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
- •Recurrent lung cancer
- •Stage IIIB, IV by AJCC 7th staging system
结局指标
主要结局
Recurrence
时间窗: 24 months
Recurrence of primary tumor documented by diagnostic imaging with or without biopsy
次要结局
未报告次要终点
研究者
Jhingook Kim, MD
Professor
Samsung Medical Center
