ENDCaP-C test accuracy study

• Register: ISRCTN
• Last refreshed on: 8 February 2021
• Main ID: ISRCTN81826545
• Date of registration: 11/05/2015
• Prospective Registration: No
• Primary sponsor: University of Birmingham
• Public title: ENDCaP-C test accuracy study
• Scientific title: Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis (ENDCaP-C): a multicentre test accuracy study
• Date of first enrolment: 13/11/2014
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN81826545
• Study type: Observational
• Study design: Non-randomised; Observational; Design type: Cohort study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Laura Magill

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology
Digestive System

Intervention(s)

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 histologically analysed and methylation status will be determined.

Patients that have a positive methylation test but negative histology will undergo a second colonoscopy at 4-12 months and an additional five biopsy samples will be taken. Histology and methylation status will be determined.

A selection of patients that have a negative methylation test but negative histology will undergo a second colonoscopy at 4-12 months and five biopsy samples will be taken. Histology and methylation status will be determined.

Study Entry: Registration only


Previous interventions:
Colonoscopy and biopsy: patients will have five biopsy samples taken at their routine surveillance colonoscopy. Biopsy samples will be histologically analysed and methylation status will be determined.

Patients that have a positive methylation test but negative histology will undergo a second colonoscopy at 6 months and an additional five biopsy samples will be taken. Histology and methylation status will be determined.

Added 10/02/2017: A selection of patients that have a negative methylation test but negative histology will undergo a second colonoscopy at 6-9 months and five biopsy samples will be taken. Histology and methylation status will be determined.

Study Entry: Registration only

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

17739

Source(s) of Monetary Support

NIHR Efficacy and Mechanism Evaluation; Grant Codes: EME/11/100/29

Ethics review

Status:
Approval date:
Contact:

First MREC approval date 30/10/2014, ref: 14/LO/1842

Results

• Results available: Yes
• Date Completed: 31/05/2018