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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
240
Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
Shaare Zedek Medical Center
Jerusalem, Israel
Development of MRI-based Index
The overall objectives of this study are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity means of MRE. The indices are aimed to be discriminative, evaluative and predictive. they 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. The data collected will be analyzed and scored by both the radiologists and the gastroenterologists. On the basis of these scores, 2 or 3 contending versions of each index will be then subjected to head-to-head evaluation by enrolling another cohort of 120 children undergoing colonoscopy and MRE/pelvic MRI. The best version for each index will be selected according to its performance in the validity, reliability and responsiveness testing. The second group of patients will not be followed longitudinally.
Time frame: 3.5 years
Exploratory
To describe the 18-month progression rate of intestinal damage in pediatric Crohn's disease, stratified by the different medications used, and disease duration at enrolment.
Time frame: 3.5 years
Exploratory
To identify biological and clinical markers, predictive of intestinal damage.
Time frame: 3.5 Years
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