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ELN multicenter analysis of phenotypic evolution and clinical outcomes

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

Observational FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · NCT07203768

This study tries to find features linked to JAK2V617F-positive essential thrombocythemia (ET) patients who later developed polycythemia vera (PV) by comparing them with matched ET patients who did not progress and with patients diagnosed with de novo PV.

Quick facts

Study typeObservational
Enrollment678 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other
Locations25 sites (Rochester, Minnesota and 24 other locations)
Trial IDNCT07203768 on ClinicalTrials.gov

What this trial studies

This is an international, multicenter retrospective observational study performed in two parts: a nested 1:1 matched case-control analysis (part A) and a comparative retrospective cohort study (part B). Part A will compare ET patients who progressed to PV (ET-to-PV cases) with matched ET controls based on year of diagnosis, age at diagnosis, and duration of ET. Part B will include patients with de novo PV to compare clinical features and outcomes with ET-to-PV cases. All diagnoses follow the 2022 International Consensus Classification criteria and data are abstracted from medical records through December 31, 2020.

Who should consider this trial

Good fit: Ideal participants are people diagnosed with ET under the 2022 ICC criteria who are JAK2V617F-positive and progressed to PV by December 31, 2020, plus matched ET controls and de novo PV cases treated at participating centers.

Not a fit: Patients without the JAK2V617F mutation, those whose diagnoses do not meet the 2022 ICC criteria, or patients whose progression occurred after December 31, 2020 are unlikely to be included or to benefit directly from the study findings.

Why it matters

Potential benefit: If successful, this work could help doctors identify ET patients at higher risk of evolving to PV so they can be monitored more closely or offered earlier treatment.

How similar studies have performed: Prior retrospective and molecular studies have suggested markers associated with progression from ET to PV but have shown mixed results, so this larger multicenter matched design aims to clarify those associations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

\- 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:

* None.

Where this trial is running

Rochester, Minnesota and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Polycythemia VeraThrombocythemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.