Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:20 AM
Study NCT ID:
NCT04842760
Status:
UNKNOWN
Last Update Posted:
2023-02-10
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis', 'timeFrame': '12 months', 'description': 'platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay'}, {'measure': 'Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis', 'timeFrame': '12 months', 'description': 'reference laboratory tests are light transmission aggregometry and serotonin release assay'}], 'secondaryOutcomes': [{'measure': 'Characterization of platelet morphology with ImageStream', 'timeFrame': '12 months', 'description': 'Analyses of data provided by the ImageStream system on platelets and platelets aggregates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet Disorder', 'Heparin-induced Thrombocytopenia', 'ImageStream cytometer', 'Platelet activation', 'Platelet aggregation'], 'conditions': ['Platelet Disorder', 'Heparin-induced Thrombocytopenia', 'Platelet Activation', 'Platelet Aggregation']}, 'descriptionModule': {'briefSummary': 'Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia \\[HIT\\]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.\n\nThis study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT\n\nExclusion Criteria:\n\n* minor patients\n* patients who have opposed the use of their personal data for research work.'}, 'identificationModule': {'nctId': 'NCT04842760', 'acronym': 'PLATELETSTREAM', 'briefTitle': 'PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer', 'orgStudyIdInfo': {'id': 'PI2021_843_0039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No platelet disorders or no HIT', 'description': 'Patients without platelet disorders or without HIT, without anti-PF4/H antibodies, without anti-aggregant treatment.'}, {'label': 'HIT patients with anti-PF4/H antibodies', 'description': 'patients with anti-PF4/H antibodies but for whom HIT was ruled out.'}, {'label': 'platelet dysfunction or HIT', 'description': 'Patients with platelet dysfunction or suffering from HIT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maïlys LE GUYADER, MD', 'role': 'CONTACT', 'email': 'leguyader.mailys@chu-amiens.fr', 'phone': '03.22.08.70.00'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Maïlys LE GUYADER, MD', 'role': 'CONTACT', 'email': 'leguyader.mailys@chu-amiens.fr', 'phone': '03.22.08.70.00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}