Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Salofalk
Pharmaceutical Form: Granules
INN or Proposed INN: mesalazine
CAS Number: 89-57-6
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 2
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical activity index = 4 Long-standing extensive or left-sided ulcerative colitis for more than 8 years Age 18-65 years Using 6-mercaptopurine or azathioprine to maintain remission For women only: sufficient anti-conception Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Dysplasia or colorectal cancer before study entry - Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection) - Colectomy - Family history of colorectal cancer - Symptomatic cholelithiasis - Cholecystitis - Coagulation disorder or use anticoagulants that can not be temporarily discontinued, precluding the taking of biopsies - Chronic renal impairment/failure - Diabetes mellitus (higher risk for developing renal disease) - Hypertension (higher risk for developing renal disease) - Allergy to 5-ASA or UDCA - Vertricular/gastric or duodenal ulcera - Asthma - For women only: Pregnancy, lactation or childbearing potential without adequate contraception - Galactose-intolerance, Lapp lactasedeficience or glucose-galactose malabsorption - Treatment with antacids containing hydroxide, hypolipidemics, high-dose calcium supplements (= 1200 mg/day), or any other medication disturbing the enterohepatic circulation - Treatment with methotrexate, riphampicine, lactulose, glucocorticosteroids - Unwillingness to be informed about accidental diagnostic findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study the chemopreventive potential of 5-aminosalicylic acid (5-ASA) and ursodeoxycholic acid (UDCA) in UC by evaluating the effect of treatment on abberant crypt foci (ACF) number, size and rate of dysplasia. ;Primary end point(s): 1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by genome-wide array based mRNA expression analysis of UC normal colonic mucosa before and after treatment. ;Secondary Objective: 1. Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by genome-wide array based mRNA expression analysis of UC normal colonic mucosa before and after treatment. 2. Improve understanding of early events in colorectal carcinogenesis by genome-wide array based mRNA expression analysis of dysplastic ACF and UC normal colonic mucosa. | — |
Countries
Netherlands
Outcome results
None listed