Colorectal NeoplasmsNCT05601609
Are Sporadic Colorectal Cancers in Young Distinct From Elderly?
An observational study of Colorectal Neoplasms, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (CRC) in young adults without genetic mutations associated with hereditary CRC syndrome and sporadic CRC in elderly individuals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 1,599 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2020to 2 Aug 2022
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Three tertiary referral hospitals between January 2010 to December 2017
Who may be able to join
- Histologically confirmed cases of adenocarcinoma in the colon and rectum
- The age at the time of diagnosis should be ≤ 40 years (for yCRC) or ≥ 70 years (for eCRC)
- Genetic testing confirmation of non-hereditary cancer.
Who cannot join
- Inflammatory bowel disease
- A family history of CRC
- A history of other cancers
- Underwent any emergency operation or palliative surgery
- The Amsterdam criteria with mutations in genes associated with APC, MLH1, MSH2, MSH6
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
In this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (CRC) in young adults without genetic mutations associated with hereditary CRC syndrome and sporadic CRC in elderly individuals.
Read the detailed description
The ambiguity in the findings among several previous studies might be because of the difference in the age of the study population, yCRC and eCRC. The family history of CRC and cancer due to Crohn's disease or ulcerative colitis were also not excluded in such previous studies. Most importantly, those studies did not rule out the risk of hereditary cancer through the genetic testing in yCRC. Since hereditary CRC accounts for approximately 34% of those under the age of 35 years, it is necessary to exclude it to accurately compare the clinicopathological characteristics of sporadic cancer developed in yCRC and eCRC.
- Conditions
- Colorectal Neoplasms
- Keywords
- young colorectal cancer patients, elderly colorectal cancer patients, sporadic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young colorectal cancer (yCRC) | 1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≤ 40 years | |
| elderly colorectal cancer (eCRC) | 1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≥ 70 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)
The 3-year overall survival (OS) in yCRC and eCRC
Measured: The OS was defined as the time period from the date of surgery to the date of death or last follow-up up to 3 years
Secondary outcomes (1)
Cancer-specific survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)
The 3-year cancer-specific survival (CSS) in yCRC and eCRC
Measured: CSS was defined as the time period from the date of surgery to the date of death from CRC up to 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start11 Nov 2020
- Primary completion10 Jun 2021
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- 1,599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Duck-Woo Kim, MD PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601609
- Sponsor's protocol ID
- B-2011/651-103
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang IJ, Kim DW, Lee J, Ahn HM, Oh HK, Kang SB, Suh JW, Kim MH, Oh HJ, Kim HK, Kim MJ, Park JW, Ryoo SB, Park KJ, Jeong SY, Oh JH. Are sporadic colorectal cancers in young patients distinct from those in elderly patients? Colorectal Dis. 2024 Jul;26(7):1405-1414. doi: 10.1111/codi.17072. Epub 2024 Jun 16.
PubMed 38881232
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Sporadic Colorectal Cancers in Young Distinct From Elderly?
- ClinicalTrials.gov ID
- NCT05601609
- Acronym / sponsor ID
- B-2011/651-103
- Conditions
- Colorectal Neoplasms
- Keywords
- young colorectal cancer patients, elderly colorectal cancer patients, sporadic colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,599 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 1 Nov 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.
In this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (CRC) in young adults without genetic mutations associated with hereditary CRC syndrome and sporadic CRC in elderly individuals.
Detailed description
The ambiguity in the findings among several previous studies might be because of the difference in the age of the study population, yCRC and eCRC. The family history of CRC and cancer due to Crohn's disease or ulcerative colitis were also not excluded in such previous studies. Most importantly, those studies did not rule out the risk of hereditary cancer through the genetic testing in yCRC. Since hereditary CRC accounts for approximately 34% of those under the age of 35 years, it is necessary to exclude it to accurately compare the clinicopathological characteristics of sporadic cancer developed in yCRC and eCRC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young colorectal cancer (yCRC) | – | –1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≤ 40 years |
| elderly colorectal cancer (eCRC) | – | –1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≥ 70 years |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Three tertiary referral hospitals between January 2010 to December 2017
Key inclusion criteria (3 listed)
- Histologically confirmed cases of adenocarcinoma in the colon and rectum
- The age at the time of diagnosis should be ≤ 40 years (for yCRC) or ≥ 70 years (for eCRC)
- Genetic testing confirmation of non-hereditary cancer.
Key exclusion criteria (5 listed)
- Inflammatory bowel disease
- A family history of CRC
- A history of other cancers
- Underwent any emergency operation or palliative surgery
- The Amsterdam criteria with mutations in genes associated with APC, MLH1, MSH2, MSH6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)
Time frame: The OS was defined as the time period from the date of surgery to the date of death or last follow-up up to 3 years
The 3-year overall survival (OS) in yCRC and eCRC
1 secondary outcome
Cancer-specific survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)
Time frame: CSS was defined as the time period from the date of surgery to the date of death from CRC up to 3years
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 1 Nov 2022.
- Derived from this study: PubMed 38881232Yang IJ, Kim DW, Lee J, Ahn HM, Oh HK, Kang SB, Suh JW, Kim MH, Oh HJ, Kim HK, Kim MJ, Park JW, Ryoo SB, Park KJ, Jeong SY, Oh JH. Are sporadic colorectal cancers in young patients distinct from those in elderly patients? Colorectal Dis. 2024 Jul;26(7):1405-1414. doi: 10.1111/codi.17072. Epub 2024 Jun 16.
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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.
Duck-Woo Kim, MD PhD principal investigator
Seoul National University Bundang Hospital
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 Neoplasms, 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 3 inclusion and 5 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 1 Nov 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?
Overall survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC) (time frame: The OS was defined as the time period from the date of surgery to the date of death or last follow-up up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601609, which also lists 1 linked publication.
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 1 Nov 2022.