Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study

This study is currently recruiting participants.

Verified October 2011 by UMC Utrecht

Sponsor:

Collaborators:

Merck

Ferring Pharmaceuticals

Information provided by (Responsible Party):

B. Oldenburg, UMC Utrecht

ClinicalTrials.gov Identifier:

NCT01464151

First received: October 31, 2011

Last updated: NA

Last verified: October 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 31, 2011
Last Updated Date	October 31, 2011
Start Date ^ICMJE	July 2011
Estimated Primary Completion Date	July 2018 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 31, 2011)	low- or high grade dysplasia or colorectal cancer during follow-up [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Official Title ^ICMJE	Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Brief 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. 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-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 or anti-TNF 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: biopsies, blood, stool
Sampling Method	Non-Probability Sample
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.
Condition ^ICMJE	Inflammatory Bowel Disease Colorectal Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	700
Estimated Completion Date	December 2018
Estimated Primary Completion Date	July 2018 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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)
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01464151
Other Study ID Numbers ^ICMJE	11-050
Has Data Monitoring Committee	No
Responsible Party	B. Oldenburg, UMC Utrecht
Study Sponsor ^ICMJE	UMC Utrecht
Collaborators ^ICMJE	Merck Ferring Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	UMC Utrecht
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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