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:
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Organization:
Study Overview
Official Title:
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERNEST
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: