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Polycythemia VeraET2PVNCT07203768

A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

An observational study of Polycythemia Vera and Thrombocythemia, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 24 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Polycythemia Vera, Thrombocythemia
How many people
678 participants
Where
24 sitesin 5 countries
Study dates
1 Dec 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • None.

Trial locations and contacts

24 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

TIZIANO BARBUI, MD contact

+39 0352675134

tbarbui@fondazionefrom.it

FRANCESCA FENILI contact

sperimentazioni@fondazionefrom.it

24 sites in 5 countries

Italy17 sites, 17 recruiting

  • A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia

    Alessandria, 15121

    Monia Marchetti, monia.marchetti@ospedale.al.it

    Monia Marchetti

    Not yet recruiting

  • ASST Papa Giovanni XXIII, SC Ematologia

    Bergamo

    Maria Luisa Ferrari, mlferrari@fondazionefrom.it

    Federico Lussana, MD

    Recruiting

  • Policlinico S. Orsola - Malpighi

    Bologna

    Francesca Palandri, MD

    Not yet recruiting

  • ASST-Spedali Civili

    Brescia, 25123

    Rosa Daffini, ctoematologia.brescia@gmail.com

    Giuseppe Rossi

    Not yet recruiting

  • AOU Careggi, Divisione di Ematologia

    Florence

    Chiara Paoli, chiara.paoli@unifi.it

    Alessandro Vanncchi, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia

    Milan

    Mattia La Monica, mattia.lamonica@ospedaleniguarda.it

    Marianna Caramella, MD

    Not yet recruiting

  • Fondazione IRCCS Cà Grande - Op. Maggiore Policlinico

    Milan

    Silvia Artuso, silvia.artuso@policlinico.mi.it

    Alessandra Iurlo, MD

    Not yet recruiting

  • Ospedale San Raffaele

    Milan

    Antonella Danese, Danese.Antonella@hsr.it

    Daniele Sannipoli, MD

    Not yet recruiting

  • ASST MONZA Ospedale San Gerardo Clinica Ematologica

    Monza, 20900

    Elena Elli, Dr, elena.elli@libero.it

    Elena Elli, Dr

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

    Naples, 80131

    novypugliese@yahoo.it

    Fabrizio Pane, Prof

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

    Novara, 28100

    Deambrogi Clara, clara.deambrogi@med.uniupo.it

    Andrea Patriarca, Dr

    Recruiting

  • Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100

    cto-oh@smatteo.pv.it

    Elisa Rumi, MD

    Not yet recruiting

  • Presidio Ospedaliero di Pescara

    Pescara

    Paola Ranalli, paola.ranalli@asl.pe.it

    Paola Ranalli, MD

    Not yet recruiting

  • Fondazione Policlinico Universitario Gemelli

    Roma

    Giulia De Santis, giulia.desantis@policlinicogemelli.it

    Stefano De Valerio, MD

    Recruiting

  • Umberto I Policlinico

    Roma

    Antonella Mosca, antonella.mosca@uniroma1.it

    Massimo Breccia, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia

    Verona

    massimiliano.bonifacio@univr.it

    Massimiliano Bonifacio, MD

    Not yet recruiting

  • Divisione Ematologia, Ospedale San Bortolo

    Vicenza, Veneto

    MD, studiclinici.ematologia@aulss8.veneto.it

    Giuseppe Carli, MD

    Recruiting

Other trials in Italy

Germany3 sites, 3 recruiting

  • University Hospital Halle

    Halle

    Sandra Ehlert, Sandra.Ehlert@uk-halle.de

    Haifa Katthrin Al-Ali, MD

    Not yet recruiting

  • Hannover Medical School

    Hanover

    Florian Heidel, MD

    Recruiting

  • University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center

    Minden

    Stephanie Jender-Bartling, Stephanie.Jender-Bartling@muehlenkreiskliniken.de

    Martin Griesshammer, MD

    Recruiting

Other trials in Germany

Spain2 sites, 2 recruiting

  • IDIBAPS, Hospital clinic

    Barcelona

    Alberto Alvarez-Llaran

    Alberto Alvarez-Llaran, MD

    Recruiting

  • 12 Octubre University Hospital

    Madrid

    Gonzalo Carrno Gomez-Tarragona, MD

    Recruiting

Other trials in Spain

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905-0001

    Active, not recruiting

Other trials in United States

United Kingdom1 site, 1 recruiting

  • Guy's and St. Thomas' NHS Foundation Trust

    London

    Claire Harrison, MD

    Recruiting

Other trials in United Kingdom

About this study

Official title: Unmasking Polycythemia Vera in Long-Standing Essential Thrombocythemia: A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).

Read the detailed description

The study will include 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.

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.

Medical subject headings
Polycythemia Vera, Thrombocytosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07203768
Study groupRoleWhat they receive
ET to PV patientsPatients JAK2V617F positive and who have progressed to PV by 31/12/2020.
ET patientsPatients 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 patientsPatients diagnosed with de novo PV (no progression from previous ET). This control group will be recruited using a 1:1 matching procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nested case-control study

    To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.

    Measured: Up to the baseline

  2. Comparative retrospective cohort study

    To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.

    Measured: Up to the baseline

Secondary outcomes (2)

  1. Nested case-control study

    To describe characteristics of ET patients who progressed to PV, including the timing of progression.

    Measured: At the time of progression

  2. Comparative retrospective cohort study

    To compare the incidence of different outcomes (vascular events, progression to myelofibrosis, progression to acute myeloid leukaemia, tumours, death) in ET patients who progressed to PV and in de novo PV patients.

    Measured: At the time of progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start1 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
678 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07203768
Sponsor's protocol ID
ET2PV
Acronym
ET2PV
Status last verified
Jul 2026
First submitted
23 Sep 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Barbui T, Thiele J, Alvarez-Larran A, Rambaldi A, Vannucchi AM, Tefferi A. From essential thrombocythemia to polycythemia vera (ET-2-PV): rationale and design of a multicenter ELN study. Ann Hematol. 2026 Mar 4;105(4):158. doi: 10.1007/s00277-026-06898-1.

    PubMed 41776088

Questions about this trial

What is this clinical trial studying?

An observational study of Polycythemia Vera and Thrombocythemia, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Italy, Germany, Spain, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TIZIANO BARBUI, MD (+39 0352675134, tbarbui@fondazionefrom.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nested case-control study (time frame: Up to the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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