Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-12 @ 8:39 PM
Study NCT ID:
NCT02862366
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic 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': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the average number of microparticles detected by flow cytometry in all subgroup', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myeloproliferative neoplasms', 'Circulating Procoagulants Microparticles'], 'conditions': ['Myeloproliferative Neoplasm']}, 'descriptionModule': {'briefSummary': 'Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.\n\nThese last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ET, PV or PMF. Healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for MNPs patients:\n\n* Age \\> 18\n* Establish MNPs Phi- diagnosis (ET, PV, MFP)\n* Consent to participate\n\nInclusion Criteria for healthy volunteers:\n\n* Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count\n* No personal thromboembolic history\n* No known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (Atrial fibrillation, etc.)\n* Not pregnant\n* Non smoker\n* For women, no hormonal contraceptives\n\nExclusion Criteria for MNPs patients:\n\n* Pregnancy\n* Patient unable to give consent'}, 'identificationModule': {'nctId': 'NCT02862366', 'acronym': 'MICROP-SMP', 'briefTitle': 'Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'RC-P0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Myelofibrosis (PMF)', 'description': 'Blood sampling during routine visit', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Essential thrombocytosis (ET)', 'description': 'Blood sampling during routine visit', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Polycythemia vera (PV)', 'description': 'Blood sampling during routine visit', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling every 6 month following the routine calendar of visit', 'armGroupLabels': ['Essential thrombocytosis (ET)', 'Polycythemia vera (PV)', 'Primary Myelofibrosis (PMF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'EFS', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'GHICL', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Agnès Charpentier, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GHICL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}