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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Genetic: Mutation

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 Type: Observational
• Enrollment (Actual): 2203

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Three tertiary referral hospitals between January 2009 to December 2019

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KRAS wildtype
KRAS codon 12 mutation	Genetic: Mutation
KRAS codon 13 mutation	Genetic: Mutation
KRAS codon 61 mutation	Genetic: Mutation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence-related factor	Recurrence in 5 years after the date of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 10, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Estimate): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: B-2203-742-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No