Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type Colorectal Cancer in First-line Treatment: a Prospective, Observational Multi-centre Study in Spain. PERSEIDA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
研究概览
简要总结
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
详细描述
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method is proposed as a technique that may be useful for analysing the RAS mutation status in different types of cancer. However, first it is necessary to evaluate the concordance between the results obtained in tumour samples and liquid biopsies.
Primary objective
• To evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild-type metastatic colorectal cancer.
Secondary objectives
- To evaluate the appearance of new RAS mutations using liquid biopsies at the moment of disease progression.
- To evaluate the appearance of new RAS mutations using liquid biopsies prior to radiological documentation of disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
时间窗: Baseline
To evaluate the RAS mutation status at baseline in liquid biopsies in two cohorts of subjects with RAS wild-type metastatic colorectal cancer: one analysed with the BEAMing (Sysmex-Inostics) technique (Cohort 1) and the other one analysed with the IdyllaTM (Biocartis) tests (Cohort 2).
次要结局
- Description of the RAS mutations using liquid biopsies at 20 +/-2 weeks after starting treatment and prior to the second radiological assessment of the disease.(at 20+/- 2 weeks after treatment start)
- Description of RAS mutations using liquid biopsies at the moment of disease progression(Median time to progression ranges from 12 to 24 months)