A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes

NCT07203768 · tracked via the Priya Life Science Germany tracker

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Phase

Observational

Started

2025-12-01

Last updated

2026-07-09

Condition(s) studied

Polycythemia VeraThrombocythemia

Study summary

International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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.

Primary outcome measure(s)

Nested case-control study — Up to the baseline
To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.
Comparative retrospective cohort study — Up to the baseline
To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.

Trial sites (24)

Facility	City	Region	Status
Mayo Clinic	Rochester	Minnesota	Active Not Recruiting
University Hospital Halle	Halle	Germany	Not Yet Recruiting
Hannover Medical School	Hanover	Germany	Recruiting
University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center	Minden	Germany	Recruiting
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardy	Not Yet Recruiting
Divisione Ematologia, Ospedale San Bortolo	Vicenza	Veneto	Recruiting
A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia	Alessandria	Italy	Not Yet Recruiting
ASST Papa Giovanni XXIII, SC Ematologia	Bergamo	Italy	Recruiting
Policlinico S. Orsola - Malpighi	Bologna	Italy	Not Yet Recruiting
ASST-Spedali Civili	Brescia	Italy	Not Yet Recruiting
AOU Careggi, Divisione di Ematologia	Florence	Italy	Recruiting
ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia	Milan	Italy	Not Yet Recruiting
Fondazione IRCCS Cà Grande - Op. Maggiore Policlinico	Milan	Italy	Not Yet Recruiting
Ospedale San Raffaele	Milan	Italy	Not Yet Recruiting
ASST MONZA Ospedale San Gerardo Clinica Ematologica	Monza	Italy	Not Yet Recruiting
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo	Naples	Italy	Not Yet Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia	Novara	Italy	Recruiting
Presidio Ospedaliero di Pescara	Pescara	Italy	Not Yet Recruiting
Fondazione Policlinico Universitario Gemelli	Roma	Italy	Recruiting
Umberto I Policlinico	Roma	Italy	Not Yet Recruiting
Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia	Verona	Italy	Not Yet Recruiting
IDIBAPS, Hospital clinic	Barcelona	Spain	Recruiting
12 Octubre University Hospital	Madrid	Spain	Recruiting
Guy's and St. Thomas' NHS Foundation Trust	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07203768 on ClinicalTrials.gov ↗ ← All trials in Germany