ELN multicenter analysis of phenotypic evolution and clinical outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hannover Medical School
  Hanover, Germany Recruiting
• University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center
  Minden, Germany Recruiting
• Divisione Ematologia, Ospedale San Bortolo
  Vicenza, Veneto, Italy Recruiting
• ASST Papa Giovanni XXIII, SC Ematologia
  Bergamo, Italy Recruiting
• AOU Careggi, Divisione di Ematologia
  Florence, Italy Recruiting
• Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
  Novara, Italy Recruiting

Study contacts

• Study coordinator: Tiziano Barbui, Md
• Email: tbarbui@fondazionefrom.it
• Phone: +39 0352675134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.