CRC chemoprevention in UC.
Recruiting
- Conditions
- lcerative colitis - Colitis ulcerosaChemoprevention - ChemopreventieColorectal cancer - Colorectaal carcinoom
- Registration Number
- NL-OMON24955
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1. Clinical activity index ¡Ü 4;
2. Long-standing extensive ulcerative colitis for more than 8 years;
Exclusion Criteria
1. Dysplasia or colorectal cancer before study entry;
2. Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, relative to the placebo group;<br /><br>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 Outcome Measures
Name Time Method 1. Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF size and rate of dysplasia, relative to the placebo group;<br /><br>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.