Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 7:03 PM
Study NCT ID:
NCT06125457
Status:
UNKNOWN
Last Update Posted:
2023-12-19
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D017098', 'term': 'IgA Deficiency'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004406', 'term': 'Dysgammaglobulinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive test result for covid-19', 'timeFrame': '1 hour after hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'IgA deficiency', 'Antibiotic therapy', 'Immunosuppressive treatments', 'Autoimmune manifestations', 'Neoplasia'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The management of patients with a selective IgA deficiency currently consists of symptomatic treatment with treatment of infections by occasional or prolonged antibiotic therapy, immunosuppressive treatments for autoimmune pathologies, symptomatic treatment of allergic manifestations.\n\nIVIG supplements are sometimes proposed in the event of recurrent infections and the demonstration of deficiencies in IgG subclasses (IgG1, 2, 3) often not sought for diagnosis The factors associated with the severity of clinical manifestations are not well identified and patients with IgA deficiency must be monitored over the long term because of the risk of the appearance of autoimmune manifestations and neoplasia. The identification of such factors could lead to the proposal of close monitoring for these patients.\n\nIgA deficiency, which is frequent, has not been identified as a risk factor for severe COVID-19 infection, probably due to a lack of studies with sufficient recruitment. The therapeutic attitude concerning patients with an IgA deficiency in the event of COVID-19 infection is therefore not consensual.\n\nThere is currently no action to be taken regarding the risk of transmission of IgA deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subject (≥18 years old) with a primary selective IgA deficiency treated at the HUS from 01/01/2005 to 01/31/2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subject (≥18 years old)\n* Subject treated at the HUS, with a primary selective IgA deficiency, considered as definitive (IgA concentration \\< 0.07g/L or total absence of IgA on immunofixation) or as probable (IgA concentration lower than two standard leads to standard for age) with no other humoral immunodeficiency and no other cause of decreased gammaglobulins 01/01/2005 to 01/31/2022.\n* Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.\n\nExclusion criteria:\n\n. Subject who expressed their opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT06125457', 'acronym': 'EpIgA', 'briefTitle': 'Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission: A Retrospective Cohort Study in Strasbourg University Hospital', 'orgStudyIdInfo': {'id': '8587'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie KORGANOW, MD, PhD', 'role': 'CONTACT', 'email': 'Anne-sophie.Korganow@chru-strasbourg.fr', 'phone': '33 3 69 55 05 21'}, {'name': 'Anne-Sophie KORGANOW, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olivier VOLLMER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeanne MALLICK, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabelle JAHN', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Immunologie Clinique - Médecine Interne - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne-Sophie KORGANOW, MD, PhD', 'role': 'CONTACT', 'email': 'Anne-sophie.Korganow@chru-strasbourg.fr', 'phone': '33 3 69 55 05 21'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}