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临床试验/NCT03336658
NCT03336658进行中(未招募)不适用

Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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