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

January 10, 2023 updated by: Fondazione per la Ricerca Ospedale Maggiore
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50134
        • AOU Careggi
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • UOC Ematologia, ASST Papa Giovanni XXIII
      • Pavia, Lombardia, Italy, 27100
        • Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
      • Varese, Lombardia, Italy, 21100
        • U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
  • Spain
      • Barcellona, Spain, 08036
        • Hospital Clinic de Barcelona
  • Sweden
      • Uddevalla, Sweden, 451 53
        • Center is Hematology Section, Uddevalla Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of death
Time Frame: 18 years
Overall Survival
18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with evolution to acute leukemia (AL)
Time Frame: 18 years
Occurrence of AL from diagnosis to last observation
18 years
Number of patients with secondary tumor (ST)
Time Frame: 18 years
Occurrence of ST from diagnosis to last observation
18 years
Number of patients with cardiovascular (CV) complications
Time Frame: 18 years
Occurrence of events from diagnosis to last observation
18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione per la Ricerca Ospedale Maggiore

Investigators

  • Study Chair: Tiziano Barbui, MD, Fondazione per la Ricerca Ospedale di Bergamo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERNEST - FROM/O1- 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelofibrosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe