Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06798805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validation of extracellular vesicles as biomarker', 'timeFrame': '1 years', 'description': 'Development of an integrated analysis of clinical data and extracellular vesicle-based scenescence biomarkers to allow the identification of a short-term prognostic index in Myeloproliferative Neoplasm patients.'}], 'primaryOutcomes': [{'measure': 'Plasma extracellular vesicle characterization', 'timeFrame': '2 years', 'description': 'Comparison of concentration (particles/mL), phenotype, and cargo between extracellular vesicles from patients and healthy donors.'}, {'measure': 'Validation of extracellular vesicles as biomarker', 'timeFrame': '2 years', 'description': "Correlation of extracellular vesicles' characterization data with markers of disease aggressiveness."}], 'secondaryOutcomes': [{'measure': 'Cell culture-derived extracellular vesicle characterization', 'timeFrame': '2 years', 'description': 'Comparison of the phenotype of extracellular vesicles derived from the supernatant of selected immune cells cultured in the presence or absence of inflammatory factors.'}, {'measure': 'Extracellular vesicle-mediated senescence', 'timeFrame': '1 years', 'description': 'Comparison of senescence biomarkers (such as p16 and p21) in selected immune cells from healthy donors in the presence or absence of extracellular vesicles from patients or healthy donors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Essential Thrombocythemia (ET)', 'Myelofibrosis (MF)', 'Polycythemia Vera (PV)']}, 'descriptionModule': {'briefSummary': 'In this study the aim is to investigate the pathogenetic role of extracellular vesicles and senescence in Myeloproliferative Neoplasms. In particular, the goal of this project is to identify possible EV-based biomarkers of senescence according to gender, which are disease-specific, biology-related, and predictive of short-term outcome in terms of Event-Free Survival and to define personalized targets for new therapeutic approaches.', 'detailedDescription': "This is a 3-year multi-centre prospective in vitro study. 120 patients with MPN (ET (n=45), PV (n=45), and MF (n=30)) will be enrolled for a period of 22 months. Follow-up: 12 months. Patients (ET=Group A; PV=Group B; MF=Group C) will be enrolled at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna and at the Haematology Centres of Reggio Emilia, Brescia, Meldola, and Ravenna. Peripheral blood samples from patients with ET, PV, and MF (Group A-C; 40 ml) and/or bone marrow samples from patients with ET and PV (Group A, B; 5 ml) will be collected at diagnosis as part of normal clinical practice. The samples will be analysed at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna in collaboration with the Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS (analysis of EV size and concentration) and with the University of Perugia (analysis of EV lipid cargo). The data analysis will be carried out in collaboration with the Department of Physics and Astronomy of the University of Bologna."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis) will be enrolled over a 28 months period. Follow-up 1 year.\n\nAs a control, sex/age matched Healthy Donors will be enrolled among volunteers of a no profit organization called AIL Bologna.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for patients:\n\n* age ≥ 18 years.\n* patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.\n* patients at first diagnosis.\n* Informed consent signed.\n\nExclusion criteria for patients:\n\n\\- patients with concomitant second neoplasia\n\nInclusion criteria for Healthy Donors:\n\n* age ≥ 18 years.\n* Informed consent signed.\n\nExclusion criteria for Healthy Donors:\n\n\\- Healthy Donors with neoplasia.'}, 'identificationModule': {'nctId': 'NCT06798805', 'briefTitle': 'Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'EVs-Sene'}, 'secondaryIdInfos': [{'id': 'FIN-RER_BU_2020_29', 'type': 'OTHER_GRANT', 'domain': 'Italian Ministry of Health'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25123', 'city': 'Brescia', 'state': 'BS', 'country': 'Italy', 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '47014', 'city': 'Meldola', 'state': 'FC', 'country': 'Italy', 'facility': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '48100', 'city': 'Ravenna', 'state': 'RA', 'country': 'Italy', 'facility': 'Ospedale S.Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42123', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Arcispedale S. Maria Nuova - IRCCS', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Lucia Catani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}