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

Sponsor

Fondazione per la Ricerca Ospedale Maggiore (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04153305

Collaborator

(none)

578

Enrollment

Locations

32.7

Anticipated Duration (Months)

96.3

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

578 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 8, 2019

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Outcome Measures

Primary Outcome Measures

Number of death [18 years]
Overall Survival

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Careggi	Firenze	FI	Italy	50134
2	UOC Ematologia, ASST Papa Giovanni XXIII	Bergamo	Lombardia	Italy	24127
3	Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia	Italy	27100
4	U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese	Varese	Lombardia	Italy	21100
5	Hospital Clínic de Barcelona	Barcellona		Spain	08036
6	Center is Hematology Section, Uddevalla Hospital	Uddevalla		Sweden	451 53