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

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ClinicalTrials.gov Identifier: NCT04153305
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

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
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 2018. 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 2018 will be recorded by authorized participating investigators.

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Study Type : Observational
Estimated 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 : October 8, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021





Primary Outcome Measures :
  1. Number of death [ Time Frame: 18 years ]
    Overall Survival


Secondary Outcome Measures :
  1. Number of patients with evolution to acute leukemia (AL) [ Time Frame: 18 years ]
    Occurrence of AL from diagnosis to last observation

  2. Number of patients with secondary tumor (ST) [ Time Frame: 18 years ]
    Occurrence of ST from diagnosis to last observation

  3. Number of patients with cardiovascular (CV) complications [ Time Frame: 18 years ]
    Occurrence of events from diagnosis to last observation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153305


Contacts
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Contact: Arianna Masciulli, PhD 0352678926 amasciulli@fondazionefrom.it
Contact: Arianna Ghirardi, PhD 0352678913 aghirardi@fondazionefrom.it

Locations
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Italy
AOU Careggi Not yet recruiting
Firenze, FI, Italy, 50134
Contact: Chiara Paoli, PhD    0557947688    chiara.paoli@unifi.it   
Principal Investigator: Alessandro M Vannucchi, MD         
UOC Ematologia, ASST Papa Giovanni XXIII Recruiting
Bergamo, Lombardia, Italy, 24127
Contact: Federica Delaini       oro@asst-pg23.it   
Principal Investigator: Alessandro Rambaldi, MD         
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo Not yet recruiting
Pavia, Lombardia, Italy, 27100
Contact: Alessia Comino    0382503084    a.comino@smatteo.pv.it   
Principal Investigator: Elisa Rumi, MD         
U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese Not yet recruiting
Varese, Lombardia, Italy, 21100
Contact: Alessia Ingrassia    0332278761    alessia.ingrassia.dm@gmail.com   
Principal Investigator: Francesco Passamonti, MD         
Sub-Investigator: Domenica Caramazza, MD         
Spain
Hospital Clínic de Barcelona Not yet recruiting
Barcellona, Spain, 08036
Contact: ALBERTO ALVAREZ LARRAN       aalvar@clinic.cat   
Principal Investigator: ALBERTO ALVAREZ LARRAN, MD         
Sweden
Center is Hematology Section, Uddevalla Hospital Not yet recruiting
Uddevalla, Sweden, 451 53
Contact: Bjorn Andreasson       bjorn.andreasson@vgregion.se   
Principal Investigator: Bjorn Andreasson, MD         
Sub-Investigator: Helna Petterson         
Sponsors and Collaborators
Fondazione per la Ricerca Ospedale Maggiore
Investigators
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Study Chair: Tiziano Barbui, MD Fondazione per la Ricerca Ospedale di Bergamo

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Responsible Party: Fondazione per la Ricerca Ospedale Maggiore
ClinicalTrials.gov Identifier: NCT04153305     History of Changes
Other Study ID Numbers: ERNEST - FROM/O1- 2019
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fondazione per la Ricerca Ospedale Maggiore:
survival
acute leukemia
second cancer
cardiovascular complication
update
disease management
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Neoplasms
Bone Marrow Diseases
Hematologic Diseases