Inflammatory Bowel DiseaseNCT01464151
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
An observational study of Inflammatory Bowel Disease and Colorectal Cancer, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease, Colorectal Cancer
- How many people
- 613 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jul 2011to 31 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis between 18 and 70 years of age. Patients should have an indication for surveillance according to the current guidelines, which means a disease duration of at least 8 years and involvement of at least 30% of the colon.
Who may be able to join
- Diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
- Disease duration ≥ 8 years
- Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion
- Age 18 - 70 years
- Signed informed consent
Who cannot join
- High grade dysplasia or colorectal cancer before inclusion
- subtotal or total colectomy before inclusion
- Clotting disorder or use of anticoagulants that can not be temporarily discontinued
- Serious comorbidities which prevent performing a colonoscopy
- Limited life expectancy
- Clinical or endoscopical disease activity (at the discretion of the treating physician)
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
AMC
Amsterdam
LUMC
Leiden, 2333 ZA
Radboud UMC
Nijmegen
UMC Utrecht
Utrecht, 3584 CX
About this study
Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future.
Objectives:
- To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.
- To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy.
- Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Keywords
- IBD, colitis, dysplasia, colorectal cancer
- Medical subject headings
- Inflammatory Bowel Diseases, Colorectal Neoplasms, Colitis
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 |
|---|---|---|
| Patients with inflammatory bowel disease | patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis between 18 and 70 years of age. Patients should have an indication for surveillance according to the current guidelines, which means a disease duration of at least 8 years and involvement of at least 30% of the colon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
low- or high grade dysplasia or colorectal cancer during follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJul 2011
- Primary completion31 May 2021
- Study completion31 May 2021
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 Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Ferring Pharmaceuticals
- Responsible party
- Principal investigator, B. Oldenburg, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464151
- Sponsor's protocol ID
- 11-050
- Status last verified
- Aug 2021
- First submitted
- 31 Oct 2011
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Wijnands AM, Elias SG, Dekker E, Fidder HH, Hoentjen F, Ten Hove JR, Maljaars PWJ, van der Meulen-de Jong AE, Mooiweer E, Ouwehand RJ, Penning de Vries BBL, Ponsioen CY, van Schaik FDM, Oldenburg B; Dutch Initiative on Crohn's and Colitis (ICC). Smoking and colorectal neoplasia in patients with inflammatory bowel disease: Dose-effect relationship. United European Gastroenterol J. 2023 Sep;11(7):612-620. doi: 10.1002/ueg2.12426. Epub 2023 Jul 28.
PubMed 37505117
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01464151
- Acronym / sponsor ID
- 11-050
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Keywords
- IBD, colitis, dysplasia, colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Ferring Pharmaceuticals
- Study start
- Jul 2011
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Nov 2011 (estimated)
- 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.
Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future.
Objectives:
- To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.
- To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy.
- Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory bowel disease | – | –patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis between 18 and 70 years of age. Patients should have an indication for surveillance according to the current guidelines, which means a disease duration of at least 8 years and involvement of at least 30% of the colon. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a diagnosis of ulcerative colitis, Crohn's colitis or indeterminate colitis between 18 and 70 years of age. Patients should have an indication for surveillance according to the current guidelines, which means a disease duration of at least 8 years and involvement of at least 30% of the colon.
Key inclusion criteria (5 listed)
- Diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
- Disease duration ≥ 8 years
- Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion
- Age 18 - 70 years
- Signed informed consent
Key exclusion criteria (6 listed)
- High grade dysplasia or colorectal cancer before inclusion
- subtotal or total colectomy before inclusion
- Clotting disorder or use of anticoagulants that can not be temporarily discontinued
- Serious comorbidities which prevent performing a colonoscopy
- Limited life expectancy
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
low- or high grade dysplasia or colorectal cancer during follow-up
Time frame: 5 years
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 17 Aug 2021.
- Derived from this study: PubMed 37505117Wijnands AM, Elias SG, Dekker E, Fidder HH, Hoentjen F, Ten Hove JR, Maljaars PWJ, van der Meulen-de Jong AE, Mooiweer E, Ouwehand RJ, Penning de Vries BBL, Ponsioen CY, van Schaik FDM, Oldenburg B; Dutch Initiative on Crohn's and Colitis (ICC). Smoking and colorectal neoplasia in patients with inflammatory bowel disease: Dose-effect relationship. United European Gastroenterol J. 2023 Sep;11(7):612-620. doi: 10.1002/ueg2.12426. Epub 2023 Jul 28.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Colorectal Cancer, run by UMC Utrecht at 4 sites in Netherlands.
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 5 inclusion and 6 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
low- or high grade dysplasia or colorectal cancer during follow-up (time frame: 5 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 NCT01464151, 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 17 Aug 2021.