Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- association between gene mutational status and overall survival
研究概览
简要总结
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.
The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Surgically resected early-stage (II-III) colorectal cancer
- •Availability of biological material
排除标准
- •Metastatic disease (stage IV) at initial diagnosis
结局指标
主要结局
association between gene mutational status and overall survival
时间窗: 24 months
the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up
association between gene mutational status and disease-free survival
时间窗: 24 months
the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first
次要结局
- Descriptives(24 months)