NCT02502656Unknown不适用
RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer: Concordance With the "Standard" Testing Method From Tumor Tissue and Review of Associated Timelines and Costs
Association des Gastroentérologues Oncologues14 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2015年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 425
- 试验地点
- 14
- 主要终点
- Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods
研究概览
简要总结
This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed metachronous or synchronous metastatic colorectal cancer
- •No prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment
- •Signed written informed consent obtained prior to any study specific screening procedures
- •Patients willing to provide a blood sample for Translational Research
排除标准
- •No tumor block available
- •Previous malignancy in the last 5 years
- •Medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent
结局指标
主要结局
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods
时间窗: Baseline
RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA
次要结局
- Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods in patients for whom circulating tumor DNA has been identified in the avalaible plasma sample.(Baseline)
- Comparison of the timelines to obtain results between the two methods(Baseline)
- Comparisons of the costs between the two methods(Baseline)
研究者
研究点 (14)
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