Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 8:38 PM
Study NCT ID:
NCT01241058
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2010-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-17', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease course', 'timeFrame': '5 years', 'description': 'describe patient characteristics, disease fenotype and course'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["pediatrics, crohn's disease, disease course, therapy"], 'conditions': ['Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations']}, 'referencesModule': {'references': [{'pmid': '25354967', 'type': 'RESULT', 'citation': "Van Biervliet S, Smets F, Hofmann I, Degreef E, Hauser B, Bontems P, Vande Velde S, Arts W, Paquot I, Alliet P, Bossuyt P, Louis E, Baert F, Bauraind O, Rahier JF, Veereman G. The course of anaemia in children and adolescents with Crohn's disease included in a prospective registry. Int J Colorectal Dis. 2015 Jan;30(1):51-6. doi: 10.1007/s00384-014-2042-4. Epub 2014 Oct 30."}, {'pmid': '24761688', 'type': 'RESULT', 'citation': "De Greef E, Maus B, Smets F, Van Biervliet S, John JM, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development (BIRD). Diagnosing and treating pediatric Crohn's disease patients: is there a difference between adult and pediatric gastroenterologist's practices ? Results of the BELCRO cohort. Acta Gastroenterol Belg. 2014 Mar;77(1):25-9. No abstract available."}, {'pmid': '23664896', 'type': 'RESULT', 'citation': "De Greef E, Mahachie John JM, Hoffman I, Smets F, Van Biervliet S, Scaillon M, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, Peeters H, Baert F, D'Haens G, Rahier JF, Etienne I, Bauraind O, Van Gossum A, Vermeire S, Fontaine F, Muls V, Louis E, Van de Mierop F, Coche JC, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development. Profile of pediatric Crohn's disease in Belgium. J Crohns Colitis. 2013 Dec;7(11):e588-98. doi: 10.1016/j.crohns.2013.04.016. Epub 2013 May 9."}, {'pmid': '23650782', 'type': 'RESULT', 'citation': 'Alliet P, Desimpelaere J, Hauser B, Janssens E, Khamis J, Lewin M, De Greef E, Smets F, Paquot I, Veereman G, Souverijns G; Belgian IBD working group of BeSPGHAN. MR enterography in children with Crohn disease: results from the Belgian pediatric Crohn registry (Belcro). Acta Gastroenterol Belg. 2013 Mar;76(1):45-8.'}, {'pmid': '26835906', 'type': 'DERIVED', 'citation': 'De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132.'}]}, 'descriptionModule': {'briefSummary': "A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was created in Belgium. Over a 2 year period 257 patients are included. These patients will be follow up prospectively during 5 years. Demographic data, family history, disease presentation and disease course including medication are registered in CRF's."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "subjects under 18 yrs of age diagnosed with Crohn's disease, living in Belgium", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1-18 yrs old belgian Crohn s disease informed consent\n\nExclusion Criteria:\n\nno informed consent'}, 'identificationModule': {'nctId': 'NCT01241058', 'acronym': 'Belcro', 'briefTitle': "Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium", 'organization': {'class': 'OTHER', 'fullName': 'Belgian Society for Pediatric Gastroentrology Hepatology and Nutrition'}, 'officialTitle': "Belgian Registry of Pediatric Crohn's Disease", 'orgStudyIdInfo': {'id': 'Bespghan'}}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Brabant', 'country': 'Belgium', 'facility': 'Bespghan', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gigi Veereman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PHD Pediatric Gastroenterologist', 'investigatorFullName': 'Gigi Veereman', 'investigatorAffiliation': 'Belgian Society for Pediatric Gastroentrology Hepatology and Nutrition'}}}}