Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Failure-free Survival
研究概览
简要总结
The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.
详细描述
This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death).
The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.
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
- •Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
- •Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
- •Sufficient surgical tissue samples are available for testing;
- •untreated colon or rectal cancer patients;
- •Patient able to understand and sign written informed consent
- •No evidence of distant metastasis (M0)
排除标准
- •Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
- •Other malignant tumors;
- •Pregnant women;
- •Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
结局指标
主要结局
Failure-free Survival
时间窗: 3 years
Tumor regression grade
时间窗: 1 year
For rectal cancer patients who receive neoadjuvant treatment
次要结局
- Overall survival(3 years)