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

Myelofibrosis Clinical Trial

— ERNEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153305
• Other study ID #: ERNEST - FROM/O1- 2019
• Status: Completed
• Start date: October 8, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2023
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelofibrosis
• Myeloproliferative Disorders
• Neoplasms

Locations

Country	Name	City	State
Italy	UOC Ematologia, ASST Papa Giovanni XXIII	Bergamo	Lombardia
Italy	AOU Careggi	Firenze	FI
Italy	Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese	Varese	Lombardia
Spain	Hospital Clínic de Barcelona	Barcellona
Sweden	Center is Hematology Section, Uddevalla Hospital	Uddevalla

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Countries where clinical trial is conducted

Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of death	Overall Survival	18 years
Secondary	Number of patients with evolution to acute leukemia (AL)	Occurrence of AL from diagnosis to last observation	18 years
Secondary	Number of patients with secondary tumor (ST)	Occurrence of ST from diagnosis to last observation	18 years
Secondary	Number of patients with cardiovascular (CV) complications	Occurrence of events from diagnosis to last observation	18 years