NCT05657210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

13 years

First QC Date

December 10, 2022

Last Update Submit

December 10, 2022

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Recurrence-related factor

    Recurrence in 5 years after the date of surgery

Study Arms (4)

KRAS wildtype

KRAS codon 12 mutation

Genetic: Mutation

KRAS codon 13 mutation

Genetic: Mutation

KRAS codon 61 mutation

Genetic: Mutation

Interventions

MutationGENETIC
KRAS codon 12 mutationKRAS codon 13 mutationKRAS codon 61 mutation

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Three tertiary referral hospitals between January 2009 to December 2019

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Mutation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2022

First Posted

December 20, 2022

Study Start

January 1, 2009

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)