Plain English Summary
Background and study aims
Ulcerative colitis (UC) is a long-term relapsing disease affecting the large intestine (colon). Its main symptoms are diarrhoea, abdominal pain and tiredness. Previously the target of treatment for these patients was clinical remission (i.e., reduced symptoms). Recently the aim of treatment changed and doctors now try to achieve normal intestinal tissue (mucosa) at endoscopy, called mucosal healing. A new treatment target has been developed called microscopic mucosal healing, where tissue samples taken from the colon (colonic biopsies) are assessed under a microscope using a scoring system and found to be normal, but it is not yet clear which scoring system to use for this. The aim of the study is to compare three commonly used scoring systems for microscopic mucosal healing in ulcerative colitis.
Who can participate?
Patients with ulcerative colitis who have already undergone a colonoscopy.
What does the study involve?
Colonic biopsies taken from the participants at a previous colonoscopy are studied. These biopsies are re-assessed by three specialist doctors using three different scoring systems. The participants do not need to have a colonoscopy again.
What are the possible benefits and risks of participating?
A single scoring system will result in a better disease outcome for ulcerative colitis patients in the future. There are no possible risks because the biopsies were taken at a previous colonoscopy.
Where is the study run from?
Radboud University Medical Center (Netherlands).
When is the study starting and how long is it expected to run for?
October 2015 to April 2016.
Who is funding the study?
Investigator initiated and funded (Netherlands).
Who is the main contact?
Tessa Römkens
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2015-1993
Study information
Scientific title
Histological remission in ulcerative colitis: comparing histological activity indexes - an observational study
Acronym
Study hypothesis
To compare and validate three commonly used histological scoring systems in order to define histological mucosal healing (MH).
Ethics approval
Ethics Committee of Radboud University Medical Center, 27/08/2015, ref: 2015-1993
Study design
Single-center observational study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Ulcerative colitis
Intervention
Biopsies were taken during colonoscopy from patients with quiescent UC with endoscopical MH (Mayo score ≤ 1). All biopsies were reassessed by three blinded pathologists using the Gupta, Riley and Geboes histology scoring systems, and a global visual evaluation (GVE).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Intra- and inter-observer variability all histological indices
Secondary outcome measures
The relationship with endoscopic mucosal healing, and the relationship between the initial judgment of the primary pathologist in all scoring systems
Overall trial start date
01/10/2015
Overall trial end date
01/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A colonoscopic examination between January 2014 and July 2015
2. A well-established diagnosis of UC according to clinical and histological criteria
3. Endoscopic mucosal healing throughout the entire colon according to Mayo (≤1)
4. Randomly taken colonic biopsy specimens in both left and right colon with a clear description of the microscopic features by the pathologist
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Mayo endoscopic score > 1
2. Diagnosed with either Crohn’s disease or indeterminate colitis
Recruitment start date
01/10/2015
Recruitment end date
01/12/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Medical Center
Nijmegen
6500 HB
Netherlands
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to publish the results only and not the protocol at this stage.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list