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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 2016 by B. Oldenburg, UMC Utrecht
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464151
First Posted: November 3, 2011
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
B. Oldenburg, UMC Utrecht
October 31, 2011
November 3, 2011
October 26, 2016
July 2011
July 2018   (Final data collection date for primary outcome measure)
low- or high grade dysplasia or colorectal cancer during follow-up [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01464151 on ClinicalTrials.gov Archive Site
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Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort 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-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:

  1. 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.
  2. 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.
  3. 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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
biopsies, blood, stool
Non-Probability Sample
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.
  • Inflammatory Bowel Disease
  • Colorectal Cancer
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
December 2018
July 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Netherlands
 
 
NCT01464151
11-050
No
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B. Oldenburg, UMC Utrecht
UMC Utrecht
  • Merck Sharp & Dohme Corp.
  • Ferring Pharmaceuticals
Not Provided
UMC Utrecht
October 2016