Prognostic Value of Each Codon-specific KRAS Mutation in... | NCT05657210

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

NCT05657210

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Dec 20, 2022Actual

Enrollment

2,203Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Mutation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Dec 10, 2022

First Submission Date that Met QC Criteria

Dec 10, 2022

First Posted Date

Dec 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2022

Last Update Posted Date

Dec 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Duck-Woo Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KRAS wildtype
KRAS codon 12 mutation			Genetic: Mutation
KRAS codon 13 mutation			Genetic: Mutation
KRAS codon 61 mutation			Genetic: Mutation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mutation	Genetic		KRAS codon 12 mutation KRAS codon 13 mutation KRAS codon 61 mutation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Recurrence-related factor		Recurrence in 5 years after the date of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Three tertiary referral hospitals between January 2009 to December 2019

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009154	Mutation

Ancestor Terms

ID	Term
D014644	Genetic Variation
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided