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European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study

F

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Status

Completed

Conditions

Myelofibrosis

Study type

Observational

Funder types

Other

Identifiers

NCT04153305
ERNEST - FROM/O1- 2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,010 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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