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 patients
    Patients JAK2V617F positive and who have progressed to PV by 31/12/2020.
  • Arm: ET patients
    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.
  • Arm: PV de novo patients
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-0001
Ayalew Tefferi, MD (PRINCIPAL_INVESTIGATOR)

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