Myelofibrosis
Conditions
Keywords
survival, acute leukemia, second cancer, cardiovascular complication, update, disease management
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* previous registration in the ERNEST registry (2012 - 2014) * diagnosis of MF performed between January 2001 and 2012 December * Signed informed consent to continue participation in the registry
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of death | 18 years | Overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with evolution to acute leukemia (AL) | 18 years | Occurrence of AL from diagnosis to last observation |
| Number of patients with secondary tumor (ST) | 18 years | Occurrence of ST from diagnosis to last observation |
| Number of patients with cardiovascular (CV) complications | 18 years | Occurrence of events from diagnosis to last observation |
Countries
Italy, Spain, Sweden
Outcome results
None listed