Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 27
- 主要终点
- Tumour markers assessment
研究概览
简要总结
The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.
Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.
A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.
The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Colo-rectal cancer (advanced or metastatic)
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •Absence of patient's consent
结局指标
主要结局
Tumour markers assessment
时间窗: Within 1 week after patient registration
Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
次要结局
未报告次要终点