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

Completed

• Conditions: Myelofibrosis

• Registration Number: NCT04153305
• Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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 Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1010

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of death	18 years	Overall Survival

Secondary Outcome Measures

Name	Time	Method
Number of patients with secondary tumor (ST)	18 years	Occurrence of ST from diagnosis to last observation
Number of patients with evolution to acute leukemia (AL)	18 years	Occurrence of AL from diagnosis to last observation
Number of patients with cardiovascular (CV) complications	18 years	Occurrence of events from diagnosis to last observation

Trial Locations

Locations (6)

AOU Careggi; 🇮🇹 Firenze, FI, Italy

Hospital Clínic de Barcelona; 🇪🇸 Barcellona, Spain

Center is Hematology Section, Uddevalla Hospital; 🇸🇪 Uddevalla, Sweden

UOC Ematologia, ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, Lombardia, Italy

Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Lombardia, Italy

U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese; 🇮🇹 Varese, Lombardia, Italy