Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 6:18 AM
Study NCT ID:
NCT06019234
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537703', 'term': 'Juvenile systemic scleroderma'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-10-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The therapeutic response was evaluated by the EULAR DAS 28 -CRP', 'timeFrame': 'at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', 'Juvenile Systemic Sclerosis', 'Immunosuppressive treatments'], 'conditions': ['Juvenile Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.\n\nThe incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level.\n\nThe proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor.\n\nComplications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided.\n\nThe main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor subject (\\<18 years old) having a systemic sclerosis between 01/01/2012 and 30/06/2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Minor subject (\\<18 years old)\n* Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.\n* Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.\n\nExclusion criteria:\n\n\\- Subject (or his parents) having expressed his (their) opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT06019234', 'acronym': 'JSSc', 'briefTitle': 'Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort', 'orgStudyIdInfo': {'id': '9028'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ariane ZALOSZYC, MD', 'role': 'CONTACT', 'email': 'ariane.zaloszyc@chru-strasbourg.fr', 'phone': '33 3 88 12 77 49'}, {'name': 'Rouba BECHARA, MD', 'role': 'CONTACT', 'email': 'Rouba.bechara@chru-strasbourg.fr', 'phone': '33 3 88 12 77 49'}, {'name': 'Ariane ZALOSZYC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rouba BECHARA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Léa JACQUEL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Cécile RAMEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Linda ROSSI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meizner ULRICH, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irène LEMELLE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte REBELLE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascal PILLET, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pauline CHOQUET, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Pédiatrie 1 - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Ariane ZALOSZYC, MD', 'role': 'CONTACT', 'email': 'ariane.zaloszyc@chru-strasbourg.fr', 'phone': '33 3 88 12 77 42'}, {'name': 'Rouba BECHARA, MD', 'role': 'CONTACT', 'email': 'Rouba.bechara@chru-strasbourg.fr', 'phone': '33 3 88 12 77 42'}], 'overallOfficials': [{'name': 'Ariane ZALOSZYC, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}