A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
ET2PV
Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
1 other identifier
observational
678
5 countries
25
Brief Summary
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedDecember 26, 2025
December 1, 2025
5 months
September 23, 2025
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Nested case-control study
To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.
Up to the baseline
Comparative retrospective cohort study
To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.
Up to the baseline
Secondary Outcomes (2)
Nested case-control study
At the time of progression
Comparative retrospective cohort study
At the time of progression
Study Arms (3)
ET to PV patients
Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.
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.
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.
Eligibility Criteria
Nested case-control study: the prevalence of at least one of the following proliferative conditions in the control group, a neutrophil/lymphocyte ratio (N/L ratio) above the median, an LDH above the median, being JAK2V617F homozygous and having splenomegaly. Comparative retrospective cohort study: it is known that the incidence of the composite outcome (vascular events, cancers, progression to myelofibrosis, progression to acute myeloid leukemia, death) in PV de novo patients.
You may qualify if:
- \- ET patients (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) who are JAK2V617F positive and have progressed to PV (diagnosed according to "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria) by 31/12/2020. The date of PV diagnosis will be defined as the index date and this group of patients will be defined as ET-to-PV cases.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Mayo Clinic
Rochester, Minnesota, 55905-0001, 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, 27100, Italy
Divisione Ematologia, Ospedale San Bortolo
Vicenza, Veneto, Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia
Alessandria, 15121, Italy
ASST Papa Giovanni XXIII, SC Ematologia
Bergamo, Italy
ASST-Spedali Civili
Brescia, 25123, 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, 20900, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, 28100, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
TIZIANO BARBUI, MD
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2025
First Posted
October 2, 2025
Study Start
December 1, 2025
Primary Completion
April 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
December 26, 2025
Record last verified: 2025-12