Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04800458
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'C537560', 'term': 'Jacobs syndrome'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'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'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with a diagnosis of autoimmune thrombocytopenia among those in whom will be identified anti-platelet antibodies in direct and indirect MAIPA', 'timeFrame': '12 months after baseline'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with chronic ITP', 'timeFrame': '12 months after baseline'}, {'measure': 'serum Thrombopoietin concentration', 'timeFrame': 'At baseline and 12 months after baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Monoclonal antibody immobilization of platelet antigens assay', 'MAIPA', 'Anti-platelet antibodies', 'Thrombopoietin'], 'conditions': ['Thrombocytopenia', 'Immune Thrombocytopenia', 'Myelodysplasia']}, 'descriptionModule': {'briefSummary': 'Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old;\n* Patients with thrombocytopenia \\<100 G/L, checked twice, having ruled out false thrombocytopenia by platelet aggregation and acute leukemia by smear;\n* No treatment started;\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research);\n* Person affiliated or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Secondary ITP;\n* False thrombocytopenia;\n* Patients who have been transfused with platelets for less than 7 days with efficacy;\n* Patient treated for thrombocytopenia (48 hours of corticosteroid therapy is tolerated and is not an exclusion criteria);\n* Patient with acute leukemia;\n* Pregnant or breastfeeding woman;\n* False thrombocytopenia;\n* Patient under guardianship, curatorship or any other legal protection regime.'}, 'identificationModule': {'nctId': 'NCT04800458', 'acronym': 'APAT', 'briefTitle': 'Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Contribution of Anti-platelet Antibodies Identified With" Monoclonal Antibody Immobilization of Platelet Antigens" Assay (MAIPA) in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis', 'orgStudyIdInfo': {'id': 'CHUBX 2020/61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thrombocytopenic patients', 'interventionNames': ['Biological: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': '* Thrombopoietin : 7 ml whole blood.\n* Anti-platelet antibodies free : 14 ml whole blood.\n* Anti-platelet antibodies bound :\n\nIf the platelet count is ≥ 50 G / L : 14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is \\< 50 G / L and ≥ 20 G / L : 28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is \\< 20 G / L and ≥ 10 G / L: 42 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation ; If the platelet count is \\< 10 G / L : 49 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation.', 'armGroupLabels': ['thrombocytopenic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-françois.viallard@chu-bordeaux.fr', 'phone': '05.57.65.64.83', 'phoneExt': '+33'}, {'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pierre DUFFAU, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sophie DIMICOLI-SALAZAR, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - service de médecine interne', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'centralContacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-françois.viallard@chu-bordeaux.fr', 'phone': '05.57.65.64.83', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry for Health and Solidarity, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}