Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06134102
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Laboratory Characteristics of Polycythemia Vera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1150}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term survival', 'timeFrame': '6 years', 'description': "To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival"}], 'secondaryOutcomes': [{'measure': 'Thrombosis', 'timeFrame': '6 years', 'description': 'To assess the incidence of thrombotic events on PV patients'}, {'measure': 'Haemorrhages', 'timeFrame': '6 years', 'description': 'To assess the incidence of haemorrhagic events on PV patients'}, {'measure': 'Therapies', 'timeFrame': '6 years', 'description': 'To assess the use of high-cost therapies'}, {'measure': 'Therapies Toxicity', 'timeFrame': '6 years', 'description': 'To assess the toxicity of therapies'}, {'measure': 'Therapies Efficacy', 'timeFrame': '6 years', 'description': 'To assess the effects of therapies'}, {'measure': 'Development of second neoplasms', 'timeFrame': '6 years', 'description': 'To assess the incidence of second malignancies'}, {'measure': 'Evolution to acute leukemias', 'timeFrame': '6 years', 'description': 'To assess the incidence of acute leukaemias'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycythemia Vera']}, 'descriptionModule': {'briefSummary': "The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival", 'detailedDescription': 'The structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. The electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on Polycythemia Vera. Patients will be followed and treated within the care pathway provided by normal clinical practice.\n\nThe following elements will be considered in each patient: age, recent and remote pathological history, characteristics of PV onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. All useful data will be collected exclusively through consultation of outpatient medical records.\n\nThe planned enrollment period is 60 months (January 2019-December 2023). The observation period of enrolled patients is at least 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The incidence of PV is approximately 11 x 1,000,000 patient-years. For the purpose of the registry, clinical/laboratory data collection will be expanded to 22 Hematology Centers experienced in the study of chronic myeloproliferative neoplasms. Overall, about 150 new diagnoses per year are expected from all Centers. Considering that about 20 percent of patients will not be able to be included for various reasons (lack of diagnosis according to WHO2017 criteria, patient's failure to refer to Hematology Centers, refusal to participate in the study), the registry is expected to include clinical data from about 2000 cases diagnosed from 2000 to the year 2023.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with PV according to WHO 2017 criteria,\n* Obtaining informed consent for data collection and processing\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06134102', 'acronym': 'PV-ARC', 'briefTitle': 'Clinical and Laboratory Characteristics of Polycythemia Vera', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Clinical and Laboratory Characteristics of Polycythemia Vera', 'orgStudyIdInfo': {'id': '483/2018/Oss/AOUBo'}}, 'contactsLocationsModule': {'locations': [{'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Ospedale Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '89124', 'city': 'Reggio Calabria', 'state': 'Calabria', 'country': 'Italy', 'facility': 'Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': "IRCCS Policlinico Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '44124', 'city': 'Ferrara', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '41125', 'city': 'Modena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '43126', 'city': 'Parma', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '29121', 'city': 'Piacenza', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'AUSL di Piacenza - Palazzine Medicine Specialistiche', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '48121', 'city': 'Ravenna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Dipartimento Oncoematologico - AUSL della Romagna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42123', 'city': 'Reggio Emilia', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova - IRCCS', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '47923', 'city': 'Rimini', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Ospedale Infermi Rimini', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'zip': '33100', 'city': 'Udine', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'A.O.U. Integrata di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '00161', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '16132', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '16132', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'IRCCS per l\'oncologia -Ospedale Policlinico "San Martino"', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Ospedale San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'A.O.U. Città della Salute e della Scienza - Presidio Molinette', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '09131', 'city': 'Cagliari', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '95124', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '61122', 'city': 'Pesaro', 'state': 'The Marches', 'country': 'Italy', 'facility': 'A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'AOU di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '37134', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'A.O.U. Integrata Verona - Borgo Roma', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}