Crohn’s disease Digestive System Crohn disease [regional enteritis]
Conditions
Interventions
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 fr
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
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 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
Exclusion criteria: METRIC cohort: 1. Enrolled in the METRIC study but not part of the final new diagnosis cohort
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed