Study of Biomarkers in Tissue Samples of Patients With Stage III Colon Cancer Treated With Adjuvant Chemotherapy Comprising Fluorouracil-Based Regimens(B-CAST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,128
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.
详细描述
OBJECTIVES:
- Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
- Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
Patients' enzyme expression levels are compared with their clinical data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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
Disease-free survival
时间窗: Until the day on which an event reveals during the 5 year observational period
Relapse-free survival
时间窗: Until the day on which an event reveals during the 5 year observational period
Relationship between expression levels of enzymes and disease-free survival, relapse-free survival, and overall survival
时间窗: 5 years after the end of registration
Relationship between expression levels of enzymes and adverse effects
时间窗: 5 years after the end of registration
次要结局
未报告次要终点