Condition category
Digestive System
Date applied
21/01/2019
Date assigned
12/03/2019
Last edited
05/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Crohn’s disease (CD) is an inflammatory condition of the bowel that can sometimes be very severe ("disabling"), requiring powerful drugs or surgery. It is important to treat patients with disabling disease as early as possible because this improves long-term health. However, it is not possible to give these powerful drugs to all patients because of risks and side effects. We need a better way to predict which patients will get disabling disease, and so most need this powerful treatment. A study called METRIC has just been completed to test the accuracy of bowel scanning (magnetic resonance enterography, MRE and ultrasound, US) when diagnosing CD. In the current study, the researchers will not perform any new patient interventions or have any direct patient contact. Instead, they want to determine if the MRE and US scans that the patients have already had can not only DIAGNOSE Crohn’s, but also PREDICT who will get disabling disease in the future.

Who can participate?
Patients aged 16 years or over with Crohn's disease who took part in the METRIC study, and patients who have had MRE or US scans as part of normal care (i.e. not in the METRIC study)

What does the study involve?
To find out who develops severe (disabling) disease and who does not, patients’ medical records are monitored for a longer period than originally planned in the METRIC study (increasing it from 6 months to an average of 5 years). Once it is known which patients have developed disabling disease, a statistical model is developed to test if the MRE and US scans help make better predictions about future health. If this prediction model has promise then it will be tested in a separate group of patients to prove that it works reliably for most patients with CD.

What are the possible benefits and risks of participating?
Participants do not themselves benefit from participating in this study because they would have been diagnosed with Crohn’s disease for at least 4 years and will have undergone treatment since their original diagnosis. There are no risks of participating in this study as there are no additional tests or interventions which the participants will need to undergo.

Where is the study run from?
University College Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2015 to September 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mrs Anvi Wadke
cctu.metricfu@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anvi Wadke

ORCID ID

Contact details

Trial Manager
Comprehensive Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
2nd Floor
90 High Holborn
London
WC1V 6LJ
United Kingdom
+44 (0)20 7907 4687
cctu.metricfu@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

40339

Study information

Scientific title

Magnetic resonance enterography as a predictor of disabling disease in newly diagnosed Crohn's Disease

Acronym

Study hypothesis

Do MRE and ultrasound abnormalities at diagnosis predict the development of disabling Crohn’s Disease?

Ethics approval

Approved 26/10/2018, London – Hampstead Research Ethics Committee, Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, Tel: +44 (0)20 7104 8127, Email: NRESCommittee.London-Hampstead@nhs.net, REC ref: 18/LO/1930

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

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

Crohn’s disease

Intervention

The study aims to determine if abnormalities in MRE and SBUS at diagnosis can predict which patients are destined to develop severe (“disabling”) Crohn’s disease, defined using existing definitions from the literature. Patients will have had more than 4 years of follow up since they were initially diagnosed with Crohn’s disease.

Magnetic Resonance Imaging (MRI) is a medical imaging technique used to visualise internal structures of the body in detail by applying magnetic field and radio frequency energy pulses. Magnetic Resonance Enterography (MRE) entails the use of MRI sequences to best show the small bowel and colon after patients drink approx 1.5 l of liquid (oral contrast) to help outline the bowel.

Ultrasound is a medical imaging technique that can generate images of the internal body structures by detecting reflections from high frequency sound waves generated by a dedicated transducer (“probe”). Small Bowel Ultrasound (SBUS) uses the same principle as all other ultrasound examinations but with specific attention directed to the small bowel.

All patients in this study will have had either MRE or SBUS at diagnosis. The researchers request access to their routine care data.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Comparative predictive ability of prognostic models incorporating MRI severity scores (MEGS, MaRIA and Lémann index) to improve predictions from a model based on clinical characteristics alone to predict the development of disabling disease at 5 year follow-up. Disabling disease is defined as per modification of Beaugerie et al Gastroenterology 2006.

Secondary outcome measures

1. Comparative predictive ability of prognostic models incorporating SBUS severity scores (SSS and US-Lémann index) to improve predictions from a model based on clinical characteristics alone to predict the development of disabling disease (modified Beaugerie definition) at 5 year follow-up
2. Comparative predictive ability of prognostic models incorporating MRI severity scores (MEGS, MaRIA, Lémann index) to improve predictions from a model based on clinical characteristics alone to predict the development of Montreal B2/B3 disease or Liège severe disease at 5 year follow-up*
3. Comparative predictive ability of prognostic models incorporating SBUS severity scores (SSS and US-Lémann index) to improve predictions from a model based on clinical characteristics alone to predict the development of Montreal B2/B3 disease or Liège severe disease at 5 year follow-up*
4. Comparative predictive ability of MRE-based and SBUS-based models for disabling disease at 5 year follow-up
5. Identification of the best combination of individual MRE and SBUS features for prediction of disabling Crohn’s disease (all definitions) within 5 years of new diagnosis
6. Average per-patient and national healthcare costs incurred within 5 years of a new diagnosis of Crohn’s disease
7. Patient, disease phenotype and imaging characteristics associated with higher economic costs within 5 years of diagnosis

Overall trial start date

15/03/2015

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

METRIC cohort:
1. Enrolled in the METRIC study, new diagnosis cohort AND
2. Formed part of the final new diagnosis cohort (i.e. with a confirmed diagnosis of Crohn's disease and underwent relevant study interventions and follow-up). METRIC new diagnosis cohort inclusion criteria were:
2.1. Aged 16 years or more
2.2. Newly diagnosed with Crohn's disease based on endoscopic, histological, clinical and radiological findings, OR
2.3. Highly suspected of Crohn's disease based on characteristic endoscopic, imaging and/or histological features but pending final diagnosis (only participants who ultimately were confirmed to have Crohn's disease will continue in this extension study) AND
3. Have given signed consent to be part of METRIC-EF

Retrospective cohort:
1. Aged 16 years or more and received a new diagnosis of Crohn's disease based on endoscopic, histological, clinical and radiological findings
2. Dedicated enteric imaging (either MRE or SBUS) acquired according to the standards of the METRIC study and performed either < 3 months after, or < 3 months prior to the new diagnosis of Crohn's disease
3. Institutional practice is to perform MRE or SBUS in all patients with newly diagnosed Crohn's disease
4. Has > 4 years clinical follow-up data, or anticipated to have such follow-up data by the time of consensus endpoint meetings (mid 2020)
5. Have given signed consent to be part of METRIC-EF

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 207; UK Sample Size: 207

Participant exclusion criteria

METRIC cohort:
1. Enrolled in the METRIC study but not part of the final new diagnosis cohort

Recruitment start date

25/03/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital
235 Euston Road Fitzrovia
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
Kings Cross
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/59/17

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal by October 2021.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes