IBD inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of ulcerative colitis, crohn*s colitis or indeterminate colitis 2. Disease duration * 8 years 3. Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion 4. Age 18 * 70 years 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. subtotal or total colectomy before inclusion 2. Clotting disorder or use of anticoagulants that can not be temporarily discontinued 3. Serious comorbidities which prevent performing a colonoscopy 4. Limited life expectancy 5. Clinical or endoscopical disease activity (at the discretion of the treating physician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is neoplasia defined as low- or high grade dysplasia or colorectal cancer during follow-up. The following parameters will be compared between patients that developed neoplasia and patients that did not develop neoplasia: 1. Mucosal healing, which is defined as the absence of endoscopic signs of past or present inflammation during endoscopy 2. Maintenancy therapy (5-ASA >1200mg/day, at least 6 months; aTNF* compounds for at least 6 months) 3. Expression of tumormarkers of interest (P53, K-RAS) in colonic biopsies 4. Expression of microRNA*s miR-17-3p and miR92 in serum 5. Known endoscopic risk factors including extent and severity of inflammation, signs of previous inflammation, presence of post-inflammatory polyps and strictures 6. Histological extent and severity of inflammation and signs of previous inflammation 7. Patient characteristics including family history for CRC, concomitant diagnosis of primary sclerosing cholangitis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters will be the differences between patients with and without neoplasia during follow-up of: 1. Data obtained from the diet questionnaire will be used to identify dietery factors (fibre intake, consumption of red meat) associated with development of neoplasia during follow-up. 2. Expression of tumormarkers (bv P53, K-RAS) in faeces 3. Frequency (relative), functional and molecular characteristics of T cell subsets present in intestinal biopsies and peripheral blood samples. | — |
Countries
Netherlands
Outcome results
None listed