Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-03-05 @ 2:38 PM
Study NCT ID:
NCT04153305
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D016609', 'term': 'Neoplasms, Second Primary'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1010}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death', 'timeFrame': '18 years', 'description': 'Overall Survival'}], 'secondaryOutcomes': [{'measure': 'Number of patients with evolution to acute leukemia (AL)', 'timeFrame': '18 years', 'description': 'Occurrence of AL from diagnosis to last observation'}, {'measure': 'Number of patients with secondary tumor (ST)', 'timeFrame': '18 years', 'description': 'Occurrence of ST from diagnosis to last observation'}, {'measure': 'Number of patients with cardiovascular (CV) complications', 'timeFrame': '18 years', 'description': 'Occurrence of events from diagnosis to last observation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['survival', 'acute leukemia', 'second cancer', 'cardiovascular complication', 'update', 'disease management'], 'conditions': ['Myelofibrosis']}, 'descriptionModule': {'briefSummary': "The Fondazione per la Ricerca Ospedale di Bergamo (FROM) decided to propose and promote the completion of ERNEST registry: the aim of the project is to obtain up-to-date estimates of clinical outcome of these patients in primary and secondary Myelofibrosis that have been included in the 'original' ERNEST study. The last was conducted between 2012 and beginning of 2015 including 1292 patients with Myelofibrosis, but it was interrupted in 2015 because of bankruptcy of the previous sponsor.", 'detailedDescription': 'Follow-up of patients already been registered in the ERNEST registry resulting alive and/or in active surveillance at November 2014 (Blood 2014 124:1849) will be updated retrospectively until December 2020. Data collection will be centralized at Fondazione per la Ricerca Ospedale di Bergamo (FROM), and performed by a web-based and Electronic Data Capture (EDC) system through ad hoc electronic case report forms (e-CRFs). The e-CRFs system will be pre-filled with pre-existing data collected from cases already entered in the registry. Information on therapies received and outcome events occurred (in term of death, evolution to acute leukemia, secondary cancer and cardiovascular complications) until December 2020 will be recorded by authorized participating investigators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years old or more, with diagnosis of Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) performed according WHO 2001 or WHO 2008, between 2001 and 2012.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous registration in the ERNEST registry (2012 - 2014)\n* diagnosis of MF performed between January 2001 and 2012 December\n* Signed informed consent to continue participation in the registry\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04153305', 'acronym': 'ERNEST', 'briefTitle': 'European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study', 'organization': {'class': 'OTHER', 'fullName': 'FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS'}, 'officialTitle': 'European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study', 'orgStudyIdInfo': {'id': 'ERNEST - FROM/O1- 2019'}}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'state': 'FI', 'country': 'Italy', 'facility': 'AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '24127', 'city': 'Bergamo', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'UOC Ematologia, ASST Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '21100', 'city': 'Varese', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '451 53', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Center is Hematology Section, Uddevalla Hospital', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}], 'overallOfficials': [{'name': 'Tiziano Barbui, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione per la Ricerca Ospedale di Bergamo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}