An observational study in Polycythemia Vera and Thrombocythemia, sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS. Recruiting at 24 sites in 5 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Observational
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
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:
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:
Furthermore, to have at least 5 years of follow-up, de novo PV patients must be diagnosed no later than 2020.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 678 is above the median of 240 across 44 observational studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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.
Exclusion Criteria:
Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.
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.
Patients diagnosed with de novo PV (no progression from previous ET). This control group will be recruited using a 1:1 matching procedure.
Nested case-control study
To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.
Time frame: 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.
Time frame: Up to the baseline
Nested case-control study
To describe characteristics of ET patients who progressed to PV, including the timing of progression.
Time frame: At the time of progression
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.
Time frame: At the time of progression
Not enrolling at this site — choose another above.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS