Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04003220
Status:
UNKNOWN
Last Update Posted:
2022-11-28
First Post:
2019-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'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': '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'the samples for research will be taken in the department where the patient is:\n\n* Blood sampling: 5 ACD-A tubes (Acid Citrate Dextrose) and 2 EDTA tubes (for 30 ICTUS patients, 20 ITP patients, and 20 patients with MDS)\n* One supplementary tube of bone marrow (for 10 patients with ICTUS, and 10 Healthy controls)\n* 25 Hair bulbs (for 20 ICTUS patients)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of clonality in patients with ICTUS', 'timeFrame': 'Day 1', 'description': 'identification of mutations in genes known to be involved in clonal expansion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombocytopenia', 'Purpura, Thrombocytopenic', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia', 'detailedDescription': 'This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this project we will study 30 patients with ICTUS, 20 ITP with immunological features, 20 MDS patients and 10 Healthy volunteers (normal bone marrow donors, obtained during a sternotomy performed in the cardiac surgery unit).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80\n* Nosological criteria for thrombocytopenic patients:\n* ICTUS: acquired thrombocytopenia lasting\\>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.\n* ITP: Diagnosis of ITP is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia. There is no "gold standard" test that can reliably establish the diagnosis. We are concerned that this group of patients may include ICTUS patients.\n* ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab) and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will use these patients as non-ICTUS, ITP positive controls.\n* Thrombocytopenic myelodysplasia: platelets \\<150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).\n* Healthy controls: patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors.\n* Affiliated person or beneficiary of a social security scheme. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Age under 18 or over 80\n* Persons placed under judicial protection,\n* Persons participating in another research including a period of exclusion still in course\n* Persons in emergency situation,\n* Pregnant or nursing women,\n* Women of childbearing age who do not benefit from effective contraception (HAS criteria),\n* Brain death or deceased persons,\n* Person who doesn\'t speak French, doesn\'t read it, doesn\'t write it, and doesn\'t have a schooling in France.'}, 'identificationModule': {'nctId': 'NCT04003220', 'acronym': 'ICTUS', 'briefTitle': 'Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker', 'orgStudyIdInfo': {'id': 'CHUBX 2018/47'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MyeloDysplastic Syndrome', 'description': 'platelets \\<150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).', 'interventionNames': ['Procedure: blood sample']}, {'label': 'Idiopathic Chronic Thrombocytopenia of Unknown Significance', 'description': 'Acquired thrombocytopenia lasting\\>6 months, without feature of dysimmunity (antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab, cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia in the family. All ICTUS patients included in the study will thus have a bone marrow aspiration.', 'interventionNames': ['Procedure: blood sample', 'Procedure: Bone marrow sample']}, {'label': 'Immune Thrombocytopenic Purpura', 'description': 'Diagnosis of Immune Thrombocytopenic Purpura (ITP) is made according to the international ITP consensus (diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive diagnosis of ITP is made when the history, physical examination, complete blood count, and examination of the peripheral blood smears do not suggest other etiologies for the thrombocytopenia', 'interventionNames': ['Procedure: blood sample']}, {'label': 'healthy volunteers undergoing cardiac surgery', 'description': 'patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors', 'interventionNames': ['Procedure: Bone marrow sample']}], 'interventions': [{'name': 'blood sample', 'type': 'PROCEDURE', 'description': 'The extra samples will be taken Blood sampling', 'armGroupLabels': ['Idiopathic Chronic Thrombocytopenia of Unknown Significance', 'Immune Thrombocytopenic Purpura', 'MyeloDysplastic Syndrome']}, {'name': 'Bone marrow sample', 'type': 'PROCEDURE', 'description': 'This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls', 'armGroupLabels': ['Idiopathic Chronic Thrombocytopenia of Unknown Significance', 'healthy volunteers undergoing cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel GALICIER, MD', 'role': 'CONTACT', 'email': 'lionel.galicier@aphp.fr', 'phone': '+331.42.49.96.90'}, {'name': 'Lionel GALICIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Immunopathologie Clinique - Hôpital Saint Louis - AP HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33600', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu PERNOT, MD', 'role': 'CONTACT', 'email': 'mathieu.pernot@chu-bordeaux.fr', 'phone': '+335.57.65.69.69'}, {'name': 'Mathieu PERNOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '33600', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Noel MILPIED', 'role': 'CONTACT', 'email': 'noel.milpied@chu-bordeaux.fr'}, {'name': 'Krimo BOUABDALLAH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie-Sarah DILHUYDY', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noel MILPIED', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François VIALLARD, Prof', 'role': 'CONTACT', 'email': 'jean-francois.viallard@chu-bordeaux.fr'}, {'name': 'Jean-François VIALLARD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'service de médecine interne et maladies infectieuses - Groupe hospitalier Sud', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'centralContacts': [{'name': 'Chloé JAMES, MD,PhD', 'role': 'CONTACT', 'email': 'chloe.james@chu-bordeaux.fr', 'phone': '+335 57 65 64 78'}], 'overallOfficials': [{'name': 'JAMES, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}