Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT07203768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013922', 'term': 'Thrombocytosis'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 678}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nested case-control study', 'timeFrame': 'Up to the baseline', 'description': 'To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.'}, {'measure': 'Comparative retrospective cohort study', 'timeFrame': 'Up to the baseline', 'description': 'To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.'}], 'secondaryOutcomes': [{'measure': 'Nested case-control study', 'timeFrame': 'At the time of progression', 'description': 'To describe characteristics of ET patients who progressed to PV, including the timing of progression.'}, {'measure': 'Comparative retrospective cohort study', 'timeFrame': 'At the time of progression', 'description': 'To compare the incidence of different outcomes (vascular events, progression to myelofibrosis, progression to acute myeloid leukaemia, tumours, death) in ET patients who progressed to PV and in de novo PV patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycythemia Vera', 'Thrombocythemia']}, 'descriptionModule': {'briefSummary': 'International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).', 'detailedDescription': 'The study will include ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.\n\nPart A - Nested case-control study Controls for ET-to-PV cases will be patients diagnosed with ET, according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria, JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.\n\nFor each patient who progressed to PV (case), a control will be selected with the following characteristics:\n\n* year of ET diagnosis (+/-2 years as compared to the date of the case);\n* age at ET diagnosis (+/-3 years as compared to the age of the case);\n* duration of ET disease (+/-2 years as compared to the period between the diagnosis of ET and the index date of the respective case).\n\nPart B - Comparative retrospective cohort study\n\nPatients diagnosed with de novo PV (no progression from previous ET) according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" data criteria, will be recruited using a 1:1 matching procedure according to the following characteristics:\n\n* year of PV diagnosis (+/-2 years as compared to the date of the case);\n* age at PV diagnosis (+/-3 years as compared to the age of the case);\n* duration of PV disease (+/-2 years as compared to the period between PV diagnosis and the last follow-up of the respective case).\n\nFurthermore, to have at least 5 years of follow-up, de novo PV patients must be diagnosed no later than 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nested case-control study: the prevalence of at least one of the following proliferative conditions in the control group, a neutrophil/lymphocyte ratio (N/L ratio) above the median, an LDH above the median, being JAK2V617F homozygous and having splenomegaly.\n\nComparative retrospective cohort study: it is known that the incidence of the composite outcome (vascular events, cancers, progression to myelofibrosis, progression to acute myeloid leukemia, death) in PV de novo patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT07203768', 'acronym': 'ET2PV', 'briefTitle': 'A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS'}, 'officialTitle': 'Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes', 'orgStudyIdInfo': {'id': 'ET2PV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ET to PV patients', 'description': 'Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.'}, {'label': 'ET patients', 'description': 'Patients JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.'}, {'label': 'PV de novo patients', 'description': 'Patients diagnosed with de novo PV (no progression from previous ET). This control group will be recruited using a 1:1 matching procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Ayalew Tefferi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Halle', 'country': 'Germany', 'contacts': [{'name': 'Sandra Ehlert', 'role': 'CONTACT', 'email': 'Sandra.Ehlert@uk-halle.de'}, {'name': 'Haifa Katthrin Al-Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hanover', 'country': 'Germany', 'contacts': [{'name': 'Florian Heidel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Minden', 'country': 'Germany', 'contacts': [{'name': 'Stephanie Jender-Bartling', 'role': 'CONTACT', 'email': 'Stephanie.Jender-Bartling@muehlenkreiskliniken.de'}, {'name': 'Martin Griesshammer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Vicenza', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Divisione Ematologia, Ospedale San Bortolo', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}, {'zip': '15121', 'city': 'Alessandria', 'country': 'Italy', 'facility': 'A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'ASST Papa Giovanni XXIII, SC Ematologia', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'ASST-Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Caocci', 'role': 'CONTACT', 'email': 'giovanni.caocci@unica.it'}, {'name': 'Giovanni Caocci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Businco', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Catania', 'country': 'Italy', 'contacts': [{'name': 'Arianna Sbriglione', 'role': 'CONTACT', 'email': 'sbriglionearianna@gmail.com'}, {'name': 'Giuseppe Palumbo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Policlinico Vittorio Emanuele - PO Gaspare Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'country': 'Italy', 'contacts': [{'name': 'Chiara Paoli', 'role': 'CONTACT', 'email': 'chiara.paoli@unifi.it'}, {'name': 'Alessandro Vanncchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Careggi, Divisione di Ematologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Silvia Artuso', 'role': 'CONTACT', 'email': 'silvia.artuso@policlinico.mi.it'}, {'name': 'Alessandra Iurlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Cà Grande - Op. Maggiore Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Antonella Danese', 'role': 'CONTACT', 'email': 'Danese.Antonella@hsr.it'}, {'name': 'Francesca Lunghi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'ASST MONZA Ospedale San Gerardo Clinica Ematologica', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Pescara', 'country': 'Italy', 'contacts': [{'name': 'Paola Ranalli', 'role': 'CONTACT', 'email': 'paola.ranalli@asl.pe.it'}, {'name': 'Paola Ranalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio Ospedaliero di Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Giulia De Santis', 'role': 'CONTACT', 'email': 'giulia.desantis@policlinicogemelli.it'}, {'name': 'Stefano De Valerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Antonella Mosca', 'role': 'CONTACT', 'email': 'antonella.mosca@uniroma1.it'}, {'name': 'Massimo Breccia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Umberto I Policlinico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'IDIBAPS, Hospital clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '12 Octubre University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Claire Harrison, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guy's and St. Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'TIZIANO BARBUI, MD', 'role': 'CONTACT', 'email': 'tbarbui@fondazionefrom.it', 'phone': '+39 0352675134'}, {'name': 'FRANCESCA FENILI', 'role': 'CONTACT', 'email': 'sperimentazioni@fondazionefrom.it'}], 'overallOfficials': [{'name': 'TIZIANO BARBUI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}