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临床试验/NCT05657210
NCT05657210已完成不适用

Does KRAS Codon 13 Mutation Have Prognostic Value in Colorectal Cancer?

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 2,203 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,203
试验地点
1
主要终点
5-year Overall survival (OS) of KRAS wildtype and each codon-specific KRAS mutation

研究概览

简要总结

This retrospective study reviewed 3,144 patients who underwent surgery for colorectal cancer. This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer.

详细描述

This study was designed to comprehend the clinicopathological characteristics associated with individual codon-specific KRAS mutations in colorectal cancer including codon 12, 13, and 61. Furthermore, the main objective of this study was to determine whether KRAS codon 13 mutation could serve as a prognostic biomarker of colorectal cancer in a relatively large cohort of subjects. Overall survival (OS) and recurrence-free survival (RFS) were calculated from the date of surgery and compared using the Kaplan-Meier method and log-rank test. For analysis of risk factors for tumor recurrence, Cox proportional hazards regression model was used with the covariance input criterion set as < 0.1. Patients were subdivided based on primary tumor location (colon versus rectum), and MSI status (MSS/MSI-low versus MSI-high).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients underwent surgery for colorectal cancer from January 2009 to December 2019.

排除标准

  • incomplete data on KRAS mutation
  • incomplete data on microsatellite instability (MSI) status
  • dual or triple KRAS mutation

结局指标

主要结局

5-year Overall survival (OS) of KRAS wildtype and each codon-specific KRAS mutation

时间窗: from the date of surgery to the event(death) up to 5 years

5-year Recurrence-free survival (RFS) of KRAS wildtype and each codon-specific KRAS mutation

时间窗: from the date of surgery to the event(recurrence and death) up to 5 years

次要结局

  • Recurrence-related factor(Recurrence in 5 years after the date of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duck-Woo Kim

Professor

Seoul National University Bundang Hospital

研究点 (1)

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