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| Name | Class |
|---|---|
| Children's Hospital of Eastern Ontario | OTHER |
| McMaster Children's Hospital | OTHER |
| IWK Health Centre | OTHER |
| Alberta Children |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 120 Children with Crohn's disease undergoing MRE & colonoscopy will be enrolled and followed for 18 months. MRE exam will be repeated at 18 months. |
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| Group 2 | Active Comparator | 120 children with Crohn's disease undergoing colonoscopy will be recruited and will have an MRE/pelvic MRI performed. The two or three contending versions of each index (PICMI and pMEDIC) developed based on Group 1, will be then subjected to head-to-head evaluation of Group 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRE | Device | Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3.5 years |
| Exploratory |
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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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Turner | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35872072 | Derived | Focht G, Cytter-Kuint R, Greer MC, Pratt LT, Castro DA, Church PC, Walters TD, Hyams J, Navon D, Martin de Carpi J, Ruemmele F, Russell RK, Gavish M, Griffiths AM, Turner D. Development, Validation, and Evaluation of the Pediatric Inflammatory Crohn's Magnetic Resonance Enterography Index From the ImageKids Study. Gastroenterology. 2022 Nov;163(5):1306-1320. doi: 10.1053/j.gastro.2022.07.048. Epub 2022 Jul 22. | |
| 31136561 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| UNKNOWN |
| The Hospital for Sick Children | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Connecticut Children's Medical Center | OTHER |
| Nationwide Children's Hospital | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Hasbro Children's Hospital | OTHER |
| C.S. Mott Children's Hospital | OTHER |
| Hospital Sant Joan de Deu | OTHER |
| Hospital Materno-Infantil de Málaga | OTHER |
| Hôpital Necker-Enfants Malades | OTHER |
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
| Yorkhill Hospital | UNKNOWN |
| Dr. von Hauner Children's Hospital | OTHER |
| Klinikum Stuttgart | OTHER |
| Royal Children's Hospital | OTHER |
| Sydney Children's Hospitals Network | OTHER |
| Sheba Medical Center | OTHER_GOV |
| Soroka University Medical Center | OTHER |
| Rambam Health Care Campus | OTHER |
| Schneider Children | UNKNOWN |
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|
To identify biological and clinical markers, predictive of intestinal damage.
| 3.5 Years |
| Derived |
| Weiss B, Turner D, Griffiths A, Walters T, Herman-Sucharska I, Coppenrath E, Anupindi SA, Towbin AJ, O'Brien K, Silverstein J, Navas V, Koletzko S, Sladek M, Gavish M, Amitai MM; ImageKids study group. NCT01881490. Simple Endoscopic Score of Crohn Disease and Magnetic Resonance Enterography in Children: Report From ImageKids Study. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):461-465. doi: 10.1097/MPG.0000000000002404. |
| 30981008 | Derived | Cozijnsen MA, Ben Shoham A, Kang B, Choe BH, Choe YH, Jongsma MME, Russell RK, Ruemmele FM, Escher JC, de Ridder L, Koletzko S, Martin-de-Carpi J, Hyams J, Walters T, Griffiths A, Turner D. Development and Validation of the Mucosal Inflammation Noninvasive Index For Pediatric Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):133-140.e1. doi: 10.1016/j.cgh.2019.04.012. Epub 2019 Apr 10. |
| 29501599 | Derived | Weinstein-Nakar I, Focht G, Church P, Walters TD, Abitbol G, Anupindi S, Berteloot L, Hulst JM, Ruemmele F, Lemberg DA, Leach ST, Cytter R, Greer ML, Griffiths AM, Turner D; ImageKids study group. Associations Among Mucosal and Transmural Healing and Fecal Level of Calprotectin in Children With Crohn's Disease. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1089-1097.e4. doi: 10.1016/j.cgh.2018.01.024. Epub 2018 Mar 2. |
| D007410 | Intestinal Diseases |