Actively Recruiting

Age: 18Years - 100Years
All Genders
ID07203768

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

Led by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Updated on 2025-12-26

678

Participants Needed

25

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an international multicenter retrospective observational study to understand the progression and outcomes of patients with Essential Thrombocythemia (ET) who carry the JAK2V617F mutation and have developed Polycythemia Vera (PV). The study includes two parts: a nested case-control study and a comparative retrospective cohort study. It aims to compare patients who progressed from ET to PV with those who did not, as well as patients diagnosed with PV without prior ET. The study groups consist of ET-to-PV patients, ET patients who did not progress to PV, and patients diagnosed with de novo PV. Matching is done to ensure comparable groups based on year and age at diagnosis, as well as disease duration. The ET-to-PV cases are identified by the date of PV diagnosis up to the end of 2020, with controls matched to these cases. The de novo PV patients must have been diagnosed by 2020 to allow at least 5 years of follow-up. Participants' medical records will be reviewed retrospectively to gather data up to the baseline and at the time of progression, if applicable. Researchers will analyze clinical outcomes and phenotypic evolution, using the date of PV diagnosis as a key reference point. The study does not involve any interventions or treatments and relies on existing patient data collected from multiple centers. Participation involves no active treatment or visits, focusing on data analysis for up to several years of follow-up.

CONDITIONS

Brief Title

A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Diagnosed with Essential Thrombocythemia according to the International consensus classification of myeloid neoplasms and acute leukemias - 2022 criteria
  • JAK2V617F positive
  • Patients who have progressed to Polycythemia Vera by 31/12/2020 (ET-to-PV cases)
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to baseline

Participants undergo assessment to confirm diagnosis and classify their disease status according to established criteria.

1 to 2 visits depending on cohort assignment

Long-term Monitoring

Duration - At least 5 years of follow-up

Participants are observed over time to study disease progression and clinical outcomes.

Periodic visits for follow-up assessments

Trial Site Locations

Total: 25 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55905-0001

Not Yet Recruiting

2

University Hospital Halle

Halle, Germany

Not Yet Recruiting

3

Hannover Medical School

Hanover, Germany

Not Yet Recruiting

4

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

Minden, Germany

Not Yet Recruiting

5

Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy, 27100

Not Yet Recruiting

6

Divisione Ematologia, Ospedale San Bortolo

Vicenza, Veneto, Italy

Not Yet Recruiting

7

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

Alessandria, Italy, 15121

Not Yet Recruiting

8

ASST Papa Giovanni XXIII, SC Ematologia

Bergamo, Italy

Actively Recruiting

9

ASST-Spedali Civili

Brescia, Italy, 25123

Not Yet Recruiting

10

Ospedale Businco

Cagliari, Italy

Not Yet Recruiting

11

AOU Policlinico Vittorio Emanuele - PO Gaspare Rodolico

Catania, Italy

Not Yet Recruiting

12

AOU Careggi, Divisione di Ematologia

Florence, Italy

Not Yet Recruiting

13

ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia

Milan, Italy

Not Yet Recruiting

14

Fondazione IRCCS Cà Grande - Op. Maggiore Policlinico

Milan, Italy

Not Yet Recruiting

15

Ospedale San Raffaele

Milan, Italy

Not Yet Recruiting

16

ASST MONZA Ospedale San Gerardo Clinica Ematologica

Monza, Italy, 20900

Not Yet Recruiting

17

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

Naples, Italy, 80131

Not Yet Recruiting

18

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, Italy, 28100

Not Yet Recruiting

19

Presidio Ospedaliero di Pescara

Pescara, Italy

Not Yet Recruiting

20

Fondazione Policlinico Universitario Gemelli

Roma, Italy

Not Yet Recruiting

21

Umberto I Policlinico

Roma, Italy

Not Yet Recruiting

22

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

Verona, Italy

Not Yet Recruiting

23

IDIBAPS, Hospital clinic

Barcelona, Spain

Actively Recruiting

24

12 Octubre University Hospital

Madrid, Spain

Actively Recruiting

25

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

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Research Team

T

TIZIANO BARBUI, MD

F

FRANCESCA FENILI

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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