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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464151
• Other study ID #: 11-050
• Status: Completed
• Start date: July 2011
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam
Netherlands	LUMC	Leiden
Netherlands	Radboud UMC	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Ferring Pharmaceuticals, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	low- or high grade dysplasia or colorectal cancer during follow-up		5 years