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
  Purpose

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
Inflammatory Bowel Disease
Colorectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • low- or high grade dysplasia or colorectal cancer during follow-up [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

biopsies, blood, stool


Estimated Enrollment: 700
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464151

Locations
Netherlands
LUMC Recruiting
Leiden, Netherlands, 2333 ZA
Contact: A.E. van der Meulen, MD, PhD       ae.meulen@lumc.nl   
Principal Investigator: A.E van der Meulen, MD, PhD         
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Erik Mooiweer, MD    +31 887550722    E.Mooiweer@umcutrecht.nl   
Sub-Investigator: Erik Mooiweer, MD         
Sponsors and Collaborators
UMC Utrecht
Merck Sharp & Dohme Corp.
Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: B. Oldenburg, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01464151     History of Changes
Other Study ID Numbers: 11-050
Study First Received: October 31, 2011
Last Updated: October 31, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
IBD
colitis
dysplasia
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on July 22, 2014