sing imaging to improve the prediction of disabling Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn’s disease; Digestive System; Crohn disease [regional enteritis]

• Registration Number: ISRCTN76899103
• Lead Sponsor: niversity College London

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36192092/ (added 04/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Study Completion: 2022-12-31
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 198

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.