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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by UMC Utrecht
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
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

October 31, 2011
October 31, 2011
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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
Not Provided
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.
Not Provided

*   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)
Both
18 Years to 70 Years
No
Netherlands
 
NCT01464151
11-050
No
B. Oldenburg, UMC Utrecht
UMC Utrecht
  • Merck Sharp & Dohme Corp.
  • Ferring Pharmaceuticals
Not Provided
UMC Utrecht
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP