A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Purpose
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
Conditions
- Polycythemia Vera
- Thrombocythemia
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| ET to PV patients | Patients JAK2V617F positive and who have progressed to PV by 31/12/2020. | |
| 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. | |
| 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. |
More Details
- Status
- Recruiting
- Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
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.