Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Evaluation of CTC features
研究概览
简要总结
Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.
详细描述
This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC.
Prospective monocenter open-label study.
In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient of more than 18 years old
- •Histological diagnosis of colic adenocarcinoma metastatic or not
- •Before any treatment with systemic chemotherapy
- •Patient affiliated to, or beneficiating of the national security
- •Patient having signed informed consent
排除标准
- •Patient with previous chemothrapy treatment
- •Patient with more than one evolutive tumoral pathology
- •Patient under long-term immunosuppressor treatment
- •Patient with severe infection
- •Pregnant or breasting woman
- •Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
结局指标
主要结局
Evaluation of CTC features
时间窗: Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression.
Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.
次要结局
未报告次要终点