跳至主要内容
临床试验/NCT02364024
NCT02364024已完成不适用

Biomarker Validation Study of Linear Quantification of CD3 Positive Cells in Localized Colorectal Carcinomas, Based on the Cohort of Patient Included in PETACC8 International Phase III Trial (NCT00265811)

Federation Francophone de Cancerologie Digestive0 个研究点目标入组 856 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
856
主要终点
Time to Recurrence (TTR)

研究概览

简要总结

The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.

详细描述

Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.

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 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient included in PETACC08 study
  • Signed informed consent for translational study
  • FFPE tumor sample available for CD3 staining

排除标准

  • Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

结局指标

主要结局

Time to Recurrence (TTR)

时间窗: 2 years

TTR is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or death due to disease recurrence) whichever occured first or last follow-up ( Last news for patients without event (censored data))

次要结局

  • Disease-Free Survival (DFS)(2 years)
  • Overall Survival (OS)(until death)

研究者

发起方
Federation Francophone de Cancerologie Digestive
申办方类型
Other
责任方
Sponsor

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