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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657210
• Other study ID #: B-2203-742-101
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2203
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Genetic:
• Mutation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recurrence-related factor		Recurrence in 5 years after the date of surgery