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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of death | Overall Survival | 18 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with evolution to acute leukemia (AL) | Occurrence of AL from diagnosis to last observation | 18 years |
| Number of patients with secondary tumor (ST) | Occurrence of ST from diagnosis to last observation |
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Inclusion Criteria:
Exclusion Criteria:
None
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tiziano Barbui, MD | Fondazione per la Ricerca Ospedale di Bergamo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi | Florence | FI | 50134 | Italy | ||
| UOC Ematologia, ASST Papa Giovanni XXIII |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 18 years |
| Number of patients with cardiovascular (CV) complications | Occurrence of events from diagnosis to last observation | 18 years |
| Bergamo |
| Lombardy |
| 24127 |
| Italy |
| Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardy | 27100 | Italy |
| U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese | Varese | Lombardy | 21100 | Italy |
| Hospital ClĂnic de Barcelona | Barcelona | 08036 | Spain |
| Center is Hematology Section, Uddevalla Hospital | Uddevalla | 451 53 | Sweden |
| D009369 | Neoplasms |