Prognostic Value of Each Codon-specific KRAS Mutation in Colorectal Cancer

Completed

• Conditions: Colorectal Cancer
• Interventions: Genetic: Mutation

• Registration Number: NCT05657210
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-10
• Study First Submitted QC: 2022-12-10
• Last Update Submitted: 2022-12-10
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2203

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KRAS codon 12 mutation	Mutation	-
KRAS codon 13 mutation	Mutation	-
KRAS codon 61 mutation	Mutation	-

Primary Outcome Measures

Name	Time	Method
5-year Overall survival (OS) of KRAS wildtype and each codon-specific KRAS mutation	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	from the date of surgery to the event(recurrence and death) up to 5 years

Secondary Outcome Measures

Name	Time	Method
Recurrence-related factor	Recurrence in 5 years after the date of surgery

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of