Clinical Epidemiology in Contemporary Patients With Myelofibrosis.
NCT Number: NCT06533813
Acronym: ERNEST-3
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myelofibrosis
Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Collaborators: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 617
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2028-12-31
Locations: Hematology Center after Prof.R.H. Yeolyan, Yerevan, Armenia|University of Copenhagen's Roskilde Hospital, Copenhagen, Denmark|Clinical Investigation Center of the Saint Louis Hospital, Paris, France|Internal Medicine C, Hematology, Oncology, Stem Cell Transplantation and Palliative Care, University Medicine Greifswald, Greifswald, Germany|University Hospital Halle Department of Hematology/Oncology, Halle, Germany|University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center Minden UKRUB, University of Bochum, Minden, Germany|Division of Haematology, Sasson University Hospital Assuta Ashdod, Ashdod, Ben-Gurion University of Negev, Ashdod, Israel|A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia, Alessandria, 15121, Italy|ASST Papa Giovanni XXIII, SC Ematologia, Bergamo, Italy|Policlinico S. Orsola - Malpighi, Unità di Ematologia, Bologna, Italy|Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di ematologia con Trapianto di midollo Osseo, Catania, Italy|AOU Careggi di Firenze, Divisione di Ematologia, Firenze, Italy|ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia, Milano, Italy|Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia, Milano, Italy|Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo, Milano, Italy|Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy|Azienda Ospedaliera Universitaria Federico II, Divisione di Ematologia, Napoli, Italy|Azienda Ospedaliero Universitaria Maggiore della Carità, SCDU Ematologia, Novara, Italy|Azienda Ospedale-Università di Padova, Dipartimento di Medicina, Padova, Italy|Università degli Studi di Padova - Policlinico Universitario, Clinica Medica 1, Padova, Italy|Fondazione IRCCS Policlinico San Matteo, Divisione di Ematologia, Pavia, Italy|Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia, Roma, Italy|Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia, Roma, Italy|A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U, Torino, 10126, Italy|ASST dei Sette Laghi (Ospedale di Circolo e F. Macchi), Divisione U.O. Ematologia, Varese, Italy|Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia, Verona, Italy|Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia, Vicenza, Italy|Institute of Oncology, State University of Medicine and Pharmacy - Department of Oncology, Hematology and Radiotherapy, Chisinau, Moldova, Republic of|Department of Hematology, University Hospital, Jagiellonian University Medical College, Cracovia, Poland|Department and Clinic of Haematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University, Wrocław, Poland|Department of Hematology and Bone Marrow Transplantation, Fundeni Clinical Institute, Bucharest, Romania|Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) - Hospital Clinic, Barcellona, Spain|Hematology and Hemotherapy Department, 12 de Octubre University Hospital, Madrid, Spain|Servicio de Hematología - Hospital Clínico Universitario de Valencia, Valencia, Spain|School of Medicine, Dentistry and Biomedical Sciences Queen's University Belfast, Belfast, United Kingdom|Guy's and St. Thomas' NHS Foundation Trust., Londra, United Kingdom

Summary:
Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from 01/01/2018 to 31/12/2027 will be enrolled into the study. Yearly follow-up updates will be scheduled until the end of data collection on 31/12/2028 or until the last available patient visit, whichever comes first. At least 1 year of follow-up will be ensured from the last patient enrolled.

Primary Outcome Measures: Overall survival according to the presence of cytopenias at diagnosis, Obtained by medical health records normally filled out in clinical practice, At diagnosis during the baseline
Secondary Outcome Measures: Frequency and types of cytopenias, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Treatments response and duration (according to modified IWG-MRT and ELN 2013 criteria, overall and by presence of cytopenias, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of major CV events (thrombosis and bleeding), overall and by presence of cytopenias and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of disease progressions (MF accelerated phase, MF blast phase/acute myeloid leukemia (AML)), overall and by presence of cytopenias and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of secondary neoplasia, overall, by site and by presence of cytopenias and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of infections, overall and by presence of cytopenias and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of adverse events (AEs) of interest, overall, by type, severity and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.|Incidence of death, overall, by cause and by presence of cytopenias and treatments received, Obtained by medical health records normally filled out in clinical practice, At baseline; 1 year follow-up.