Actively Recruiting
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
Eligibility Criteria
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)
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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