Clinical and Laboratory Characteristics of Polycythemia Vera
PV-ARC
1 other identifier
observational
1,150
1 country
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 18, 2024
February 1, 2023
5 years
October 5, 2023
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term survival
To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival
6 years
Secondary Outcomes (7)
Thrombosis
6 years
Haemorrhages
6 years
Therapies
6 years
Therapies Toxicity
6 years
Therapies Efficacy
6 years
- +2 more secondary outcomes
Eligibility Criteria
The incidence of PV is approximately 11 x 1,000,000 patient-years. For the purpose of the registry, clinical/laboratory data collection will be expanded to 22 Hematology Centers experienced in the study of chronic myeloproliferative neoplasms. Overall, about 150 new diagnoses per year are expected from all Centers. Considering that about 20 percent of patients will not be able to be included for various reasons (lack of diagnosis according to WHO2017 criteria, patient's failure to refer to Hematology Centers, refusal to participate in the study), the registry is expected to include clinical data from about 2000 cases diagnosed from 2000 to the year 2023.
You may qualify if:
- Patients diagnosed with PV according to WHO 2017 criteria,
- Obtaining informed consent for data collection and processing
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Apulia, 71013, Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, 89124, Italy
IRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, 40138, Italy
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44124, Italy
Policlinico di Modena
Modena, Emilia-Romagna, 41125, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, 43126, Italy
AUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, 29121, Italy
Dipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, 48121, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Emilia-Romagna, 42123, Italy
Ospedale Infermi Rimini
Rimini, Emilia-Romagna, 47923, Italy
A.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100, Italy
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, Lazio, 00161, Italy
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
Genoa, Liguria, 16132, Italy
IRCCS per l'oncologia -Ospedale Policlinico "San Martino"
Genoa, Liguria, 16132, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123, Italy
Ospedale San Gerardo
Monza, Lombardy, 20900, Italy
A.O.U. Città della Salute e della Scienza - Presidio Molinette
Turin, Piedmont, 10126, Italy
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
Cagliari, Sardinia, 09131, Italy
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
Catania, Sicily, 95124, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
Pesaro, The Marches, 61122, Italy
AOU di Padova
Padua, Veneto, 35128, Italy
A.O.U. Integrata Verona - Borgo Roma
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
November 18, 2023
Study Start
January 1, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 18, 2024
Record last verified: 2023-02