Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT02042560
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Immune Thrombocytopenia Pathogenesis:
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'}]}, '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': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood level T cell in ITP patients and in healthy controls', 'timeFrame': 'baseline'}, {'measure': 'blood level T cell in ITP patients after treatments', 'timeFrame': 'change from baseline at 4 to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'blood level splenic T cell in ITP patients and in healthy controls', 'timeFrame': 'baseline'}, {'measure': 'frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls', 'timeFrame': 'through study completion, an average of 3 years'}, {'measure': 'level of T follicular helper cell', 'timeFrame': 'through study completion, an average of 3 years'}]}, 'conditionsModule': {'conditions': ['Primary Immune Thrombocytopenia (ITP)']}, 'descriptionModule': {'briefSummary': 'Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.\n\nThe aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ITP', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ITP, defined as thrombocytopenia \\< 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out\n* persons who have provided written informed consent\n\nExclusion Criteria:\n\n* persons without national health insurance\n* persons under 18 years old\n* patients under guardianship\n* pregnancy\n* subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.'}, 'identificationModule': {'nctId': 'NCT02042560', 'acronym': 'PTI PARI', 'briefTitle': 'Study of Immune Thrombocytopenia Pathogenesis:', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.', 'orgStudyIdInfo': {'id': 'LORCERIE PARI 2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ITP', 'interventionNames': ['Other: Blood samples', 'Other: Spleen samples']}, {'label': 'Controls', 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'armGroupLabels': ['Controls', 'Patients with ITP']}, {'name': 'Spleen samples', 'type': 'OTHER', 'armGroupLabels': ['Patients with ITP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '57000', 'city': 'Metz', 'country': 'France', 'facility': 'CHU de METZ', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}