Colorectal CancerNCT05657210
Prognostic Value of Each Codon-specific KRAS Mutation in Colorectal Cancer
An observational study of Colorectal Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mutation
- How many people
- 2,203 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2009to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Three tertiary referral hospitals between January 2009 to December 2019
Who may be able to join
- Patients underwent surgery for colorectal cancer from January 2009 to December 2019.
Who cannot join
- incomplete data on KRAS mutation
- incomplete data on microsatellite instability (MSI) status
- dual or triple KRAS mutation
- stage IV
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Does KRAS Codon 13 Mutation Have Prognostic Value 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.
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).
- Conditions
- Colorectal Cancer
- Being tested
- Mutation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MutationGenetic
| Study group | Role | What they receive |
|---|---|---|
| KRAS wildtype | Not described | |
| KRAS codon 12 mutation | Not described Receives: Genetic: Mutation | |
| KRAS codon 13 mutation | Not described Receives: Genetic: Mutation | |
| KRAS codon 61 mutation | Not described Receives: Genetic: Mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Recurrence-free survival (RFS) of KRAS wildtype and each codon-specific KRAS mutation
Measured: 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
Measured: from the date of surgery to the event(death) up to 5 years
Secondary outcomes (1)
Recurrence-related factor
Measured: Recurrence in 5 years after the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jan 2009
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duck-Woo Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657210
- Sponsor's protocol ID
- B-2203-742-101
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does KRAS Codon 13 Mutation Have Prognostic Value in Colorectal Cancer?
- ClinicalTrials.gov ID
- NCT05657210
- Acronym / sponsor ID
- B-2203-742-101
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,203 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KRAS wildtype | – | – |
| KRAS codon 12 mutation | – | Genetic: Mutation |
| KRAS codon 13 mutation | – | Genetic: Mutation |
| KRAS codon 61 mutation | – | Genetic: Mutation |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Three tertiary referral hospitals between January 2009 to December 2019
Key inclusion criteria (1 listed)
- Patients underwent surgery for colorectal cancer from January 2009 to December 2019.
Key exclusion criteria (4 listed)
- incomplete data on KRAS mutation
- incomplete data on microsatellite instability (MSI) status
- dual or triple KRAS mutation
- stage IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutation | Genetic | KRAS codon 12 mutation, KRAS codon 13 mutation, KRAS codon 61 mutation |
Primary outcome
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
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
1 secondary outcome
Recurrence-related factor
Time frame: Recurrence in 5 years after the date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.