Polycythemia Vera
Conditions
Brief summary
The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival
Detailed description
The structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. The electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on Polycythemia Vera. Patients will be followed and treated within the care pathway provided by normal clinical practice. The following elements will be considered in each patient: age, recent and remote pathological history, characteristics of PV onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. All useful data will be collected exclusively through consultation of outpatient medical records. The planned enrollment period is 60 months (January 2019-December 2023). The observation period of enrolled patients is at least 2 years.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients diagnosed with PV according to WHO 2017 criteria, * Obtaining informed consent for data collection and processing
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term survival | 6 years | To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of second neoplasms | 6 years | To assess the incidence of second malignancies |
| Evolution to acute leukemias | 6 years | To assess the incidence of acute leukaemias |
| Thrombosis | 6 years | To assess the incidence of thrombotic events on PV patients |
| Therapies Efficacy | 6 years | To assess the effects of therapies |
| Therapies | 6 years | To assess the use of high-cost therapies |
| Therapies Toxicity | 6 years | To assess the toxicity of therapies |
| Haemorrhages | 6 years | To assess the incidence of haemorrhagic events on PV patients |
Countries
Italy