Polycythemia Vera, Thrombocythemia
Conditions
Brief 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).
Detailed description
The study will include 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. Part A - Nested case-control study Controls for ET-to-PV cases will be patients diagnosed with ET, according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" criteria, 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. For each patient who progressed to PV (case), a control will be selected with the following characteristics: * year of ET diagnosis (+/-2 years as compared to the date of the case); * age at ET diagnosis (+/-3 years as compared to the age of the case); * duration of ET disease (+/-2 years as compared to the period between the diagnosis of ET and the index date of the respective case). Part B - Comparative retrospective cohort study Patients diagnosed with de novo PV (no progression from previous ET) according to the "International consensus classification of myeloid neoplasms and acute leukemias - 2022" data criteria, will be recruited using a 1:1 matching procedure according to the following characteristics: * year of PV diagnosis (+/-2 years as compared to the date of the case); * age at PV diagnosis (+/-3 years as compared to the age of the case); * duration of PV disease (+/-2 years as compared to the period between PV diagnosis and the last follow-up of the respective case). Furthermore, to have at least 5 years of follow-up, de novo PV patients must be diagnosed no later than 2020.
Interventions
None listed
Sponsors
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nested case-control study | At the time of progression | To describe characteristics of ET patients who progressed to PV, including the timing of progression. |
| Comparative retrospective cohort study | At the time of progression | To compare the incidence of different outcomes (vascular events, progression to myelofibrosis, progression to acute myeloid leukaemia, tumours, death) in ET patients who progressed to PV and in de novo PV patients. |
Countries
Germany, Italy, Spain, United Kingdom, United States
Contacts
CONTACTTIZIANO BARBUI, MD
CONTACTFRANCESCA FENILI
STUDY_DIRECTORTIZIANO BARBUI, MD
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Outcome results
None listed