OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Feasibility of ctDNA analysis for RAS mutation analysis
研究概览
简要总结
The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.
详细描述
The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy
Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of ctDNA analysis for RAS mutation analysis
时间窗: maximum 7 days
Feasibility measures Identification of wildtype or mutated status and results delivered to clinicians * Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days * Detailed mutation type characterization is provided retrospectively. Failure parameters * Quality of samples; PB \> 5%, CPP1 major loss \< 10% * Transportation \> 3 week days * Analysis \> 3 working days * Total results delivered \> 7 days.
次要结局
- Retrospective concordance analysis(By end of study, expected after 3 years)
- Disease control rate(1 year)
- OS(3 years)
- Resistance mutations(At time of progression, data analysis expected after 3 years)
- Lead time(At time of progression, data analysis expected after 3 years)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital