Colonic NeoplasmsNCT05475288
Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer
An observational study of Colonic Neoplasms and Neoplasm Recurrence, Local, run by Radboud University Medical Center.
Trial summary
Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Neoplasm Recurrence, Local
- How many people
- 3,554 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2015
- How long will I take part?
- 6 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with stage I-III primary colon cancer in the first half of 2015.
Who may be able to join
- Histologically confirmed stage I-III primary colon carcinoma;
- Diagnosed between January 1st and June 30th of 2015;
- Surgical resection of primary colon carcinoma.
Who cannot join
- Appendiceal localization;
- Neuroendocrine tumor morphology;
About this study
Official title: Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer: a Retrospective, Population-based Cohort Study
Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined.
- Conditions
- Colonic Neoplasms, Neoplasm Recurrence, Local
- Medical subject headings
- Colonic Neoplasms, Neoplasm Recurrence, Local
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients
UNIT OF MEASUREMENT: Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients; MEASUREMENT TOOL: Registration of diagnosis of locoregionally recurrent colon cancer in the electronic patient file.
The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locoregionally recurrent colon cancer at that time point.
Measured: Three years
Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients
UNIT OF MEASUREMENT: Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients; MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary colon cancer in the electronic patient file and national pathological database (PALGA).
Clinical and pathological risk factors for the development of locoregionally recurrent colon cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locoregionally recurrent colon cancer.
Measured: Three years
Proportions of treatment given to patients with locoregionally recurrent colon cancer
UNIT OF MEASUREMENT: Proportions of treatment given to patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of treatment for locoregionally recurrent colon cancer in the electronic patient file.
Using descriptive statistics, treatment patterns of patients with locoregionally recurrent colon cancer will be identified. Groups that will be created, will also be used to assess overall survival.
Measured: Three years
Overall survival of patients with locoregionally recurrent colon cancer;
UNIT OF MEASUREMENT: Overall survival of patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database.
Overall survival will be estimated for patients with locoregionally recurrent colon cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
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 Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Other
- Enrolment
- 3,554 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hidde Swartjes, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475288
- Sponsor's protocol ID
- K20.306
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be requested through the Netherlands Cancer Registry.
Publications
Swartjes H, van Lankveld DWP, van Erning FN, Verheul HMW, de Wilt JHW, Koeter T, Vissers PAJ. Locoregionally Recurrent Colon Cancer: How Far Have We Come? A Population-Based, Retrospective Cohort Study. Ann Surg Oncol. 2023 Mar;30(3):1726-1734. doi: 10.1245/s10434-022-12689-5. Epub 2022 Oct 19.
PubMed 36261752
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer: a Retrospective, Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT05475288
- Acronym / sponsor ID
- K20.306
- Conditions
- Colonic Neoplasms, Neoplasm Recurrence, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,554 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 26 Jul 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.
Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with stage I-III primary colon cancer in the first half of 2015.
Key inclusion criteria (3 listed)
- Histologically confirmed stage I-III primary colon carcinoma;
- Diagnosed between January 1st and June 30th of 2015;
- Surgical resection of primary colon carcinoma.
Key exclusion criteria (2 listed)
- Appendiceal localization;
- Neuroendocrine tumor morphology;
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
Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients
Time frame: Three years
UNIT OF MEASUREMENT: Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients; MEASUREMENT TOOL: Registration of diagnosis of locoregionally recurrent colon cancer in the electronic patient file. The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locoregionally recurrent colon cancer at that time point.
Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients
Time frame: Three years
UNIT OF MEASUREMENT: Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients; MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary colon cancer in the electronic patient file and national pathological database (PALGA). Clinical and pathological risk factors for the development of locoregionally recurrent colon cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locoregionally recurrent colon cancer.
Proportions of treatment given to patients with locoregionally recurrent colon cancer
Time frame: Three years
UNIT OF MEASUREMENT: Proportions of treatment given to patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of treatment for locoregionally recurrent colon cancer in the electronic patient file. Using descriptive statistics, treatment patterns of patients with locoregionally recurrent colon cancer will be identified. Groups that will be created, will also be used to assess overall survival.
Overall survival of patients with locoregionally recurrent colon cancer;
Time frame: Three years
UNIT OF MEASUREMENT: Overall survival of patients with locoregionally recurrent colon cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database. Overall survival will be estimated for patients with locoregionally recurrent colon cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)
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 26 Jul 2022.
- Derived from this study: PubMed 36261752Swartjes H, van Lankveld DWP, van Erning FN, Verheul HMW, de Wilt JHW, Koeter T, Vissers PAJ. Locoregionally Recurrent Colon Cancer: How Far Have We Come? A Population-Based, Retrospective Cohort Study. Ann Surg Oncol. 2023 Mar;30(3):1726-1734. doi: 10.1245/s10434-022-12689-5. Epub 2022 Oct 19.
- Individual participant dataSharing planned: No. Data can be requested through the Netherlands Cancer Registry.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms and Neoplasm Recurrence, Local, run by Radboud University Medical Center.
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 2 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients (time frame: Three years). The study lists 4 primary outcomes in all. 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 NCT05475288, 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 26 Jul 2022.