Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 7:44 AM
Study NCT ID:
NCT04219592
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2020-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IgG-4 Levels in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'sera from healthy participants purchased from MDA will be used as control.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IgG4 measurement', 'timeFrame': '4 months', 'description': 'quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SSc', 'IgG4'], 'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.', 'detailedDescription': 'IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Medical records of SSc patients from Meir Medical Center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SSc patients\n\nExclusion Criteria:\n\n* other chronic co-morbidities'}, 'identificationModule': {'nctId': 'NCT04219592', 'acronym': 'SSc-IgG4', 'briefTitle': 'IgG-4 Levels in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls', 'orgStudyIdInfo': {'id': 'MMC-110-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SSc', 'description': '74 SSc patients aged 18 - 85', 'interventionNames': ['Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)']}, {'label': 'Healthy controls', 'description': '80 Healthy blood-donors aged 18 - 85', 'interventionNames': ['Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)']}], 'interventions': [{'name': 'IgG4 measurement (non-interventional, just obtaining data from medical records)', 'type': 'DIAGNOSTIC_TEST', 'description': 'IgG4 measurement in mg/dL', 'armGroupLabels': ['Healthy controls', 'SSc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not relevant'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Noa Rabinowicz', 'investigatorAffiliation': 'Meir Medical Center'}}}}