A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
NCT ID: NCT07203768
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
678 participants
OBSERVATIONAL
2025-12-01
2026-07-31
Brief Summary
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Detailed Description
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Part A - Nested case-control study Controls for ET-to-PV cases will be patients diagnosed with ET, according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria, JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.
For each patient who progressed to PV (case), a control will be selected with the following characteristics:
* year of ET diagnosis (+/-2 years as compared to the date of the case);
* age at ET diagnosis (+/-3 years as compared to the age of the case);
* duration of ET disease (+/-2 years as compared to the period between the diagnosis of ET and the index date of the respective case).
Part B - Comparative retrospective cohort study
Patients diagnosed with de novo PV (no progression from previous ET) according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" data criteria, will be recruited using a 1:1 matching procedure according to the following characteristics:
* year of PV diagnosis (+/-2 years as compared to the date of the case);
* age at PV diagnosis (+/-3 years as compared to the age of the case);
* duration of PV disease (+/-2 years as compared to the period between PV diagnosis and the last follow-up of the respective case).
Furthermore, to have at least 5 years of follow-up, de novo PV patients must be diagnosed no later than 2020.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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ET to PV patients
Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.
No interventions assigned to this group
ET patients
Patients JAK2V617F positive who did not progress to PV after a comparable period of time. This control group will be selected using a 1:1 matched case-control design.
No interventions assigned to this group
PV de novo patients
Patients diagnosed with de novo PV (no progression from previous ET). This control group will be recruited using a 1:1 matching procedure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
OTHER
Responsible Party
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Principal Investigators
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TIZIANO BARBUI, MD
Role: STUDY_DIRECTOR
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Locations
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Mayo Clinic
Rochester, Minnesota, United States
University Hospital Halle
Halle, , Germany
Hannover Medical School
Hanover, , Germany
University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center
Minden, , Germany
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Divisione Ematologia, Ospedale San Bortolo
Vicenza, Veneto, Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia
Alessandria, , Italy
ASST Papa Giovanni XXIII, SC Ematologia
Bergamo, , Italy
ASST-Spedali Civili
Brescia, , Italy
Ospedale Businco
Cagliari, , Italy
AOU Policlinico Vittorio Emanuele - PO Gaspare Rodolico
Catania, , Italy
AOU Careggi, Divisione di Ematologia
Florence, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia
Milan, , Italy
Fondazione IRCCS Cà Grande - Op. Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, , Italy
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, , Italy
Presidio Ospedaliero di Pescara
Pescara, , Italy
Fondazione Policlinico Universitario Gemelli
Roma, , Italy
Umberto I Policlinico
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia
Verona, , Italy
IDIBAPS, Hospital clinic
Barcelona, , Spain
12 Octubre University Hospital
Madrid, , Spain
Guy's and St. Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Sandra Ehlert
Role: primary
Stephanie Jender-Bartling
Role: primary
Role: primary
MD
Role: primary
Monia Marchetti
Role: primary
Maria Luisa Ferrari
Role: primary
Rosa Daffini
Role: primary
Giovanni Caocci
Role: primary
Arianna Sbriglione
Role: primary
Chiara Paoli
Role: primary
Mattia La Monica
Role: primary
Silvia Artuso
Role: primary
Antonella Danese
Role: primary
Elena Elli, Dr
Role: primary
Role: primary
Deambrogi Clara
Role: primary
Paola Ranalli
Role: primary
Giulia De Santis
Role: primary
Antonella Mosca
Role: primary
Role: primary
Alberto Alvarez-Llaran
Role: primary
Other Identifiers
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ET2PV
Identifier Type: -
Identifier Source: org_study_id