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The overall objectives of this study are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic MRI.
Full description
The PICMI Score and the pMEDIC are aimed to be discriminative (at one point in time), evaluative (measuring damage progression over time) and predictive. The indices will be used as endpoint measures in clinical research and also in clinical practice to identify those who are at risk for rapid disease progression and surgery.
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Inclusion criteria
Children (under 18 years of age) with established diagnosis of CD involving any location by the presence of accepted clinical, radiologic, endoscopic and histologic criteria (33, 34).
Enrolment at the time of performing ileocolonoscopy and esophageal-gastroduodenoscopy (EGD) as part of clinical care for any reason.
Children will be enrolled at any phase of the disease (at diagnosis and thereafter as required clinically). In order to ensure enough subjects with intestinal damage and since damage is progressing over time, enrolment will be stratified based on disease duration. Enrolment for each stratum of disease duration will be closed after reaching the expected sample size.
Children may be enrolled in any disease activity state (PCDAI 0-100).
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240 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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