A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Study ID
- NCT07203768
- Status
- Recruiting
Conditions
- Polycythemia Vera
- Thrombocythemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Study Details
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Dec 2025
- Primary completion
- Apr 30, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 678 participants (estimated)
Arms
- Arm: ET to PV patientsPatients JAK2V617F positive and who have progressed to PV by 31/12/2020.
- Arm: 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.
- Arm: 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.
Primary Outcome Measure
Nested case-control study [ Time Frame: Up to the baseline ]
Central Contacts
- TIZIANO BARBUI, MD+39 0352675134
- FRANCESCA FENILI
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905-0001 | Ayalew Tefferi, MD (PRINCIPAL_INVESTIGATOR) |
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