ENDCaP-C test accuracy study

Not Applicable

Completed

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

• Registration Number: ISRCTN81826545
• Lead Sponsor: niversity of Birmingham

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33439599/ (added 26/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-11
• Study Completion: 2018-05-31
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 818

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

Study & Design

• Study Type: Observational
• Study Design: Not specified