Status:
COMPLETED
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Ferring Pharmaceuticals
Conditions:
Inflammatory Bowel Disease
Colorectal Cancer
Eligibility:
All Genders
18-70 years
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, sev...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT01464151
Start Date
July 1 2011
End Date
May 31 2021
Last Update
August 17 2021
Active Locations (4)
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1
AMC
Amsterdam, Netherlands
2
LUMC
Leiden, Netherlands, 2333 ZA
3
Radboud UMC
Nijmegen, Netherlands
4
UMC Utrecht
Utrecht, Netherlands, 3584 CX