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CompletedNCT05657210Updated Dec 20, 2022

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

An observational study in Colorectal Cancer, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,203
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 2,203 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

Three tertiary referral hospitals between January 2009 to December 2019

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,203 participants (actual)
Patient registry
No

Groups and cohorts

  • KRAS wildtype
  • KRAS codon 12 mutation

    Genetic: Mutation

  • KRAS codon 13 mutation

    Genetic: Mutation

  • KRAS codon 61 mutation

    Genetic: Mutation

Interventions

  • GeneticMutation
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What researchers measure

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

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05657210
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Duck-Woo Kim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 20, 2022
Start date
Jan 1, 2009
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Dec 20, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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