Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- correlation of ITB based calculated N stage with real N stage in CRC - patients
研究概览
简要总结
All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.
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
- •Patients with newly diagnosed stages I and IV colorectal cancer (CRC)
- •Age ≥ 18 years
- •Written Informed Consent
排除标准
- •No consent
- •< 18 years
结局指标
主要结局
correlation of ITB based calculated N stage with real N stage in CRC - patients
时间窗: 24 months
次要结局
- correlation of ITB based calculated DFS with real DFS in CRC - patients(24 months)
