Clinical trial NCT06134102: Clinical and Laboratory Characteristics of Polycythemia Vera
Official title: Clinical and Laboratory Characteristics of Polycythemia Vera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycythemia Vera
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with PV according to WHO 2017 criteria,
* Obtaining informed consent for data collection and processing

Exclusion Criteria:

* None

Primary outcomes:
measure: Long-term survival
timeFrame: 6 years
Secondary outcomes:
measure: Thrombosis
timeFrame: 6 years
measure: Haemorrhages
timeFrame: 6 years
measure: Therapies
timeFrame: 6 years
measure: Therapies Toxicity
timeFrame: 6 years
measure: Therapies Efficacy
timeFrame: 6 years
measure: Development of second neoplasms
timeFrame: 6 years
measure: Evolution to acute leukemias
timeFrame: 6 years
Other outcomes:
Locations:
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
state: Calabria
city: Bologna
country: Italy
facility: IRCCS Policlinico Sant'Orsola
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
state: Emilia-Romagna
city: Modena
country: Italy
facility: Policlinico di Modena
state: Emilia-Romagna
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: AUSL di Piacenza - Palazzine Medicine Specialistiche
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Dipartimento Oncoematologico - AUSL della Romagna
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi Rimini
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O.U. Integrata di Udine
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
state: Lazio
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
state: Liguria
city: Genova
country: Italy
facility: IRCCS per l'oncologia -Ospedale Policlinico "San Martino"
state: Liguria
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Lombardia
city: Pesaro
country: Italy
facility: A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
state: Marche
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza - Presidio Molinette
state: Piemonte
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
state: Sardegna
city: Catania
country: Italy
facility: A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
state: Sicilia
city: Padova
country: Italy
facility: AOU di Padova
state: Veneto
city: Verona
country: Italy
facility: A.O.U. Integrata Verona - Borgo Roma
state: Veneto
Study officials:
References: