Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-03-27 @ 5:31 AM
Study NCT ID:
NCT03421392
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls', 'timeFrame': '18 months', 'description': 'a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin'}], 'secondaryOutcomes': [{'measure': 'Prognostic value and therapy', 'timeFrame': '18 months', 'description': 'prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constitutive thrombocytopenia', 'central thrombocytopenia', 'platelets', 'sialylation', 'flow cytometry'], 'conditions': ['Idiopathic Thrombocytopenic Purpura']}, 'referencesModule': {'references': [{'pmid': '26185093', 'type': 'BACKGROUND', 'citation': 'Li J, van der Wal DE, Zhu G, Xu M, Yougbare I, Ma L, Vadasz B, Carrim N, Grozovsky R, Ruan M, Zhu L, Zeng Q, Tao L, Zhai ZM, Peng J, Hou M, Leytin V, Freedman J, Hoffmeister KM, Ni H. Desialylation is a mechanism of Fc-independent platelet clearance and a therapeutic target in immune thrombocytopenia. Nat Commun. 2015 Jul 17;6:7737. doi: 10.1038/ncomms8737.'}, {'pmid': '19520807', 'type': 'BACKGROUND', 'citation': 'Sorensen AL, Rumjantseva V, Nayeb-Hashemi S, Clausen H, Hartwig JH, Wandall HH, Hoffmeister KM. Role of sialic acid for platelet life span: exposure of beta-galactose results in the rapid clearance of platelets from the circulation by asialoglycoprotein receptor-expressing liver macrophages and hepatocytes. Blood. 2009 Aug 20;114(8):1645-54. doi: 10.1182/blood-2009-01-199414. Epub 2009 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.\n\nRecent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3 Populations will be recruited in the study:\n\nNumber of topics planned:\n\n50 Patients in the PTI group 50 patients in the non-immunological thrombocytopenia group 50 patients in the control group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)\n* Adult patients (\\>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)\n* Adult patients (\\>18 yo) without thrombocytopenia\n* Enrolled in a Social Security system\n* Having provided informed consent\n\nExclusion Criteria:\n\n* Minor patients (\\<18 yo)\n* Enrolled in another clinical study\n* Having received corticosteroids or polyvalent immunoglobulins in the past 4\n* weeks or anti-platelet therapy or NSAID during the past 7 days\n* Having received platelet transfusion in the past fortnight\n* With proven iron deficiency\n* With drug-induced immune-allergic thrombocytopenia.\n* Pregnant and breastfeeding women,\n* guardian patients, will be excluded from this population.'}, 'identificationModule': {'nctId': 'NCT03421392', 'acronym': 'SYMPATHIC', 'briefTitle': 'Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.', 'orgStudyIdInfo': {'id': 'RC17_0346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic thrombocytopenic purpura', 'interventionNames': ['Other: non interventional study']}, {'label': 'non immunological thrombocytopenia', 'description': 'patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia', 'interventionNames': ['Other: non interventional study']}, {'label': 'without thrombocytopenia', 'interventionNames': ['Other: non interventional study']}], 'interventions': [{'name': 'non interventional study', 'type': 'OTHER', 'description': 'non interventional study', 'armGroupLabels': ['Idiopathic thrombocytopenic purpura', 'non immunological thrombocytopenia', 'without thrombocytopenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Marc Fouassier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}