NCT04153305

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,010

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

November 4, 2019

Last Update Submit

January 10, 2023

Conditions

Myelofibrosis

Keywords

survivalacute leukemiasecond cancercardiovascular complicationupdatedisease management

Outcome Measures

Primary Outcomes (1)

  • Number of death

    Overall Survival

    18 years

Secondary Outcomes (3)

  • Number of patients with evolution to acute leukemia (AL)

    18 years

  • Number of patients with secondary tumor (ST)

    18 years

  • Number of patients with cardiovascular (CV) complications

    18 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 years old or more, with diagnosis of Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) performed according WHO 2001 or WHO 2008, between 2001 and 2012.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AOU Careggi

Florence, FI, 50134, Italy

Location

UOC Ematologia, ASST Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese

Varese, Lombardy, 21100, Italy

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Center is Hematology Section, Uddevalla Hospital

Uddevalla, 451 53, Sweden

Location

MeSH Terms

Conditions

Primary MyelofibrosisNeoplasms, Second Primary

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms

Study Officials

  • Tiziano Barbui, MD

    Fondazione per la Ricerca Ospedale di Bergamo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

October 8, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)ES(1)SE(1)