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

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT01464151

Collaborator

Merck Sharp & Dohme LLC (Industry), Ferring Pharmaceuticals (Industry)

613

Enrollment

Locations

119

Duration (Months)

153.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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 (inflammatory bowel disease) -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 (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease Colorectal Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

613 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 :

Jul 1, 2011

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

low- or high grade dysplasia or colorectal cancer during follow-up [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)