Topic: Gastroenterology
Conditions
Interventions
Current interventions as of 21/05/2018:
Colonoscopy and biopsy: patients will have five biopsy samples taken at their routine surveillance colonoscopy. Biopsy samples will be histologi
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/05/2018: 1. Diagnosis of chronic ulcerative colitis with symptoms for over 10 years or diagnosis of primary sclerosing cholangitis (PSC) 2. On the surveillance programme and undergoing a routine colonoscopy during the study period 3. Willing to accept the possibility of an additional colonoscopy between 4 months and 12 months 4. No previous history of colorectal cancer 5. Aged 18 years or over 6. Be able and willing to provide written informed consent for the study Previous inclusion criteria: 1. Diagnosis of chronic ulcerative colitis of over 10 years duration and disease beyond the splenic flexure or known primary sclerosing cholangitis 2. Scheduled for surveillance colonoscopy during study period 3. Willing to accept the possibility of an additional colonoscopy between 6 months and 9 months 4. No previous history of colorectal cancer 5. Aged 18 years or over 6. Be able and willing to provide written informed consent for the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/05/2018: 1. Patients with fulminant colitis (if not PSC) 2. Bowel obstruction 3. Patients for whom it is not possible to undergo complete colonoscopies 4. Patients with proctitis only 5. Crohn's colitis patients (if no PSC) 6. Patients with unclassified IBD (if no PSC) 7. Patients with microscopic colitis (if no PSC) 8. Unable to give written informed consent 9. Aged under 18 years Previous exclusion criteria: 1. Patients with fulminant colitis 2. Bowel obstruction 3. Patients in whom it is not possible to do complete colonoscopies 4. Patients with proctitis only 5. Crohn's colitis patients 6. Patients with unclassified IBD 7. Patients with microscopic colitis 8. Unable to give written informed consent 9. Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current outcome measures as of 21/05/2018: 1. The presence of dysplasia in a mucosal biopsy taken at follow up colonoscopy at 4-12 months 2. The presence of hypermethylation and dysplasia in a mucosal biopsy taken at follow up colonoscopy at 4-12 months Previous outcome measures as of 10/02/2017: 1. The presence of dysplasia in a mucosal biopsy taken at follow up colonoscopy at 6-9 months 2. The presence of hypermethylation and dysplasia in a mucosal biopsy taken at follow up colonoscopy at 6-9 months Previous primary outcome measures: 1. The occurrence of dysplasia in mucosal biopsies taken at follow-up colonoscopy at 4-6 months in patients demonstrating hypermethylation (the positive predictive value) 2. The ability of hypermethylation to discriminate between patients with and without dysplasia in mucosal biopsies taken at follow up colonoscopy at 4-6 months (the diagnostic odds ratio) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 10/02/2017: Complications from colonoscopy Previous outcome measures: 1. Correlation of dysplasia in mucosal biopsies with the presence of significant hypermethylation in nondysplastic biopsies taken at the same procedure 2. Correlation of dysplasia with hypermethylation in the same biopsy 3. Correlation of methylation in biopsies from initial and reference colonoscopy 4. Complications from colonoscopy | — |
Countries
United Kingdom
Outcome results
None listed