Condition category
Digestive System
Date applied
22/09/2015
Date assigned
24/09/2015
Last edited
24/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
We study colonic biopsies taken from the participants at a previous colonoscopy. 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 we only study biopsies that are 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

Contact information

Type

Scientific

Primary contact

Mrs Tessa Römkens

ORCID ID

Contact details

Radboud University Medical Center
Department of Gastroenterology & Hepatology
PO Box 9101
Nijmegen
6500 HB
Netherlands

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

We conducted a study 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

Condition

Ulcerative colitis

Intervention

We studied biopsies 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 measures

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

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

Sponsor information

Organisation

Radboud University Medical Center (Netherlands)

Sponsor details

PO Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

We intend to publish the results only and not the protocol at this stage.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes