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Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
This study is currently recruiting participants.
Verified October 2016 by B. Oldenburg, UMC Utrecht
Sponsor:
UMC Utrecht
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: October 25, 2016
Last verified: October 2016
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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:
- 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 or anti-TNF 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 |
|---|
| 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 B. Oldenburg, UMC Utrecht:
Primary Outcome Measures:
- low- or high grade dysplasia or colorectal cancer during follow-up [ Time Frame: 5 years ]
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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464151
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464151
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
| 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 25, 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 |
ClinicalTrials.gov processed this record on August 21, 2017