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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05657210
Enrollment
2203
Registered
2022-12-20
Start date
2009-01-01
Completion date
2021-12-31
Last updated
2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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).

Interventions

GENETICMutation

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frame
5-year Recurrence-free survival (RFS) of KRAS wildtype and each codon-specific KRAS mutationfrom 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 mutationfrom the date of surgery to the event(death) up to 5 years

Secondary

MeasureTime frame
Recurrence-related factorRecurrence in 5 years after the date of surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026