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NCT Number: NCT05657210

Prognostic Value of Each Codon-specific KRAS Mutation 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mutation

Genetic

Primary outcomes

  1. 5-year Recurrence-free survival (RFS) of KRAS wildtype and each codon-specific KRAS mutation

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

  2. 5-year Overall survival (OS) of KRAS wildtype and each codon-specific KRAS mutation

    Time frame: from the date of surgery to the event(death) up to 5 years

Secondary outcomes

  1. Recurrence-related factor

    Time frame: Recurrence in 5 years after the date of surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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