Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT05737056
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011695', 'term': 'IgA Vasculitis'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007105', 'term': 'Immune Complex Diseases'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with the recommendations for the management of rheumatoid purpura', 'timeFrame': 'Up to two years after hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Knowledge assessment questionnaire regarding rheumatoid purpura', 'timeFrame': 'At the beginning of the study', 'description': 'Evaluation of the knowledge and current practices of general practitioners regarding rheumatoid purpura and identification of the possible obstacles to management and follow-up in primary care, using an online survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Purpura']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ecrin.app.unistra.fr/search/notice/view/ecrin-ori-356390', 'label': 'Study results'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.', 'detailedDescription': "Secondary objectives The secondary objective is to assess general practitioners current knowledge and practice of the condition and potential barriers to monitoring and follow-up by general practitioners.\n\nConduct of research Children diagnosed with rheumatoid purpura within the past 2 years at the 3 participating sites will be included in the study if parental authority holders do not object.\n\nPatients will be identified through the Medical Information Department of each hospital.\n\nParents will be contacted - first by mail, then by phone - to request permission to collect the child's medical data from medical records, and to retrieve information on the surveillance and follow-up of the disease by general practitioners up to two years after diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified by the Medical Information Department of each site. The study will be conducted on patients who have been managed for rheumatoid purpura within the last two years at one of the three participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underaged patient diagnosed with rheumatoid purpura during a visit to the pediatric emergencies of Mulhouse, Colmar and Strasbourg\n* No objection to the study from the two holders of parental authority\n\nExclusion Criteria:\n\n\\- Patient followed in the context of a genetic or malformative pathology, an immune deficiency, or a cancer'}, 'identificationModule': {'nctId': 'NCT05737056', 'acronym': 'PREEMS', 'briefTitle': 'Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace'}, 'officialTitle': 'Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians', 'orgStudyIdInfo': {'id': 'GHRMSA 1278'}, 'secondaryIdInfos': [{'id': '2022-A02687-36', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children diagnosed with rheumatoid purpura at the pediatric emergency department', 'description': 'Children diagnosed with rheumatoid purpura from admission to the pediatric emergency department up to two years of follow-up by general practitioners after hospital discharge.', 'interventionNames': ['Other: Management of rheumatoid purpura']}], 'interventions': [{'name': 'Management of rheumatoid purpura', 'type': 'OTHER', 'description': 'Collection of data on the management in pediatric emergency departments (method of diagnosis, complementary examinations, proposed treatment, number of hospitalizations, follow-up after hospital discharge).', 'armGroupLabels': ['Children diagnosed with rheumatoid purpura at the pediatric emergency department']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68000', 'city': 'Colmar', 'country': 'France', 'facility': 'Hôpitaux Civils de Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '67200', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}