Clinical and Laboratory Characteristics of Polycythemia Vera
- Conditions
- Polycythemia Vera
- Registration Number
- NCT06134102
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1150
- Patients diagnosed with PV according to WHO 2017 criteria,
- Obtaining informed consent for data collection and processing
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Therapies Efficacy 6 years To assess the effects of therapies
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
Haemorrhages 6 years To assess the incidence of haemorrhagic events on PV patients
Therapies Toxicity 6 years To assess the toxicity of therapies
Development of second neoplasms 6 years To assess the incidence of second malignancies
Therapies 6 years To assess the use of high-cost therapies
Trial Locations
- Locations (22)
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
🇮🇹Reggio Calabria, Calabria, Italy
IRCCS Policlinico Sant'Orsola
🇮🇹Bologna, Emilia Romagna, Italy
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
🇮🇹Ferrara, Emilia-Romagna, Italy
Policlinico di Modena
🇮🇹Modena, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Emilia-Romagna, Italy
AUSL di Piacenza - Palazzine Medicine Specialistiche
🇮🇹Piacenza, Emilia-Romagna, Italy
Dipartimento Oncoematologico - AUSL della Romagna
🇮🇹Ravenna, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova - IRCCS
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Ospedale Infermi Rimini
🇮🇹Rimini, Emilia-Romagna, Italy
A.O.U. Integrata di Udine
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Scroll for more (12 remaining)Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"🇮🇹Reggio Calabria, Calabria, Italy