Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-04 @ 6:57 PM
Study NCT ID:
NCT05759104
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2023-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D000038', 'term': 'Abscess'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-25', 'studyFirstSubmitDate': '2023-02-25', 'studyFirstSubmitQcDate': '2023-02-25', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No fistula', 'timeFrame': '12 month', 'description': 'Complete remission = clinical remission and biological remission and iconographic remission:\n\n* clinical remission (asymptomatic at 12 months from inclusion).\n* biological remission (normalization of biological parameters 12 months after inclusion).\n* iconographic remission (no active lesion, and in particular no visualized fistula)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fistula', 'abscess', 'pediatrics', 'medical treatment', 'surgery', 'drug'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).\n\nThe treatment of perforating Crohn's disease is not codified.", 'detailedDescription': 'The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.\n\nBiotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.\n\nIndeed, data are scarce, especially in paediatrics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* In consultations or hospitalized.\n* CHRU and CHR of Lille, Strasbourg, Colmar, Besançon, Dijon, Reims and Nancy.\n* Over the period from January 2012 to January 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minor patients (aged 3 to 18).\n* Diagnosed with Crohn's disease.\n* fistulizing crohn's disease\n\nExclusion Criteria:\n\n\\- perianal crohn disease"}, 'identificationModule': {'nctId': 'NCT05759104', 'briefTitle': "Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population", 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population", 'orgStudyIdInfo': {'id': '2022PI067'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['Adalimumab', 'Ustékinumab'], 'description': 'Drug'}, {'name': 'Stomy', 'type': 'PROCEDURE', 'otherNames': ['Resection'], 'description': 'Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'CHABOT Caroline', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}