Clinical trial NCT04153305: European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
Official title: European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelofibrosis
Keywords: survival
acute leukemia
second cancer
cardiovascular complication
update
disease management
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 1010
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of death
timeFrame: 18 years
Secondary outcomes:
measure: Number of patients with evolution to acute leukemia (AL)
timeFrame: 18 years
measure: Number of patients with secondary tumor (ST)
timeFrame: 18 years
measure: Number of patients with cardiovascular (CV) complications
timeFrame: 18 years
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: AOU Careggi
state: FI
city: Bergamo
country: Italy
facility: UOC Ematologia, ASST Papa Giovanni XXIII
state: Lombardia
city: Pavia
country: Italy
facility: Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Varese
country: Italy
facility: U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
state: Lombardia
city: Barcellona
country: Spain
facility: Hospital Clínic de Barcelona
city: Uddevalla
country: Sweden
facility: Center is Hematology Section, Uddevalla Hospital
Study officials:
affiliation: Fondazione per la Ricerca Ospedale di Bergamo
name: Tiziano Barbui, MD
role: STUDY_CHAIR
References: