Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-03 @ 5:31 AM
Study NCT ID:
NCT02158195
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunopathology of Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)', 'timeFrame': 'Change from baseline to 3 months'}, {'measure': 'physiological parameter : percentage of inhibiting LT proliferation inhibition', 'timeFrame': 'Change from baseline to 3 months'}]}, 'conditionsModule': {'conditions': ['Autoimmune Hemolytic Anemia']}, 'referencesModule': {'references': [{'pmid': '37534543', 'type': 'DERIVED', 'citation': 'Ciudad M, Ouandji S, Lamarthee B, Cladiere C, Ghesquiere T, Nivet M, Thebault M, Boidot R, Soudry-Faure A, Chevrier S, Richard C, Maillet T, Maurier F, Greigert H, Genet C, Ramon A, Trad M, Predan V, Saas P, Samson M, Bonnotte B, Audia S. Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor alpha in autoimmune hemolytic anemia and participate in Th17 polarization. Haematologica. 2024 Feb 1;109(2):444-457. doi: 10.3324/haematol.2023.282859.'}, {'pmid': '30408135', 'type': 'DERIVED', 'citation': 'Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.\n\nThe aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.\n\nThe role of treatments, such as steroids, will also be determined in patients with warm AIHA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)\n* Secondary AHAI (infections, hematological diseases, systemic diseases)\n* Naive of treatment for hemolytic anemia or in relapse\n* Older than 16\n* Able to understand written and spoken French\n* who have provided written informed consent\n* INCLUSION CRITERIA for CONTROLS\n* Persons without auto-immune disease, cancer or active infection.\n* Older than 16\n* Able to understand written and spoken French\n* who have provided written informed consent\n\nExclusion Criteria:\n\n* Cold agglutinin disease\n* Pregnancy\n* Persons without national health insurance\n\nExclusion Criteria for Controls:\n\n* Subjects treated with corticosteroids or immunosuppressants\n* Pregnancy\n* Persons without national health insurance'}, 'identificationModule': {'nctId': 'NCT02158195', 'acronym': 'IAHAI', 'briefTitle': 'Immunopathology of Autoimmune Hemolytic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study', 'orgStudyIdInfo': {'id': 'AUDIA APJ 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'interventionNames': ['Biological: blood samples']}, {'label': 'controls', 'interventionNames': ['Biological: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Patients', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'CH de Chalon-sur-Saône', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '71018', 'city': 'Mâcon', 'country': 'France', 'facility': 'CH de Mâcon', 'geoPoint': {'lat': 46.31407, 'lon': 4.82823}}, {'zip': '57000', 'city': 'Metz', 'country': 'France', 'facility': 'CH de METZ', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}