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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

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.

Condition or disease
Inflammatory Bowel Disease; Colorectal Cancer

Study Design

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Study Type :	Observational
Estimated Enrollment :	700 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Study Start Date :	July 2011
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	December 2018

Groups and Cohorts

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Group/Cohort
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.

Outcome Measures

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Primary Outcome Measures :

1. low- or high grade dysplasia or colorectal cancer during follow-up [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

biopsies, blood, stool

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

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)

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
AMC	Recruiting
Amsterdam, Netherlands
Contact: E. Dekker, MD, PhD 020 566 9111
LUMC	Recruiting
Leiden, Netherlands, 2333 ZA
Contact: A.E. van der Meulen, MD, PhD 071 526 9111
Principal Investigator: A.E van der Meulen, MD, PhD
Radboud UMC	Recruiting
Nijmegen, Netherlands
Contact: F. Hoentjen, MD, PhD 024 361 1111
UMC Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Joren ten Hove, MD +31 887550722 j.r.tenhove-2@umcutrecht.nl
Sub-Investigator: Joren ten Hove, MD

Sponsors and Collaborators

UMC Utrecht

Merck Sharp & Dohme Corp.

Ferring Pharmaceuticals

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	B. Oldenburg, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT01464151 History of Changes
Other Study ID Numbers:	11-050
First Posted:	November 3, 2011
Last Update Posted:	October 26, 2016
Last Verified:	October 2016

Keywords provided by B. Oldenburg, UMC Utrecht:

IBD; colitis; dysplasia; colorectal cancer

Additional relevant MeSH terms:

Inflammatory Bowel Diseases; Colorectal Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site	Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Rectal Diseases; Gastroenteritis