Clinical and Laboratory Characteristics of Polycythemia Vera

Polycythemia Vera Clinical Trial

— PV-ARC  

Official title:

Clinical and Laboratory Characteristics of Polycythemia Vera

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134102
• Other study ID #: 483/2018/Oss/AOUBo
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Francesca Palandri, MD, PhD
• Phone: +390512143044
• Email: francesca.palandri[@]unibo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Locations

Country	Name	City	State
Italy	IRCCS Policlinico Sant'Orsola	Bologna	Emilia Romagna
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari	Cagliari	Sardegna
Italy	A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto	Catania	Sicilia
Italy	Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna	Ferrara	Emilia-Romagna
Italy	IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST	Genova	Liguria
Italy	IRCCS per l'oncologia -Ospedale Policlinico "San Martino"	Genova	Liguria
Italy	Policlinico di Modena	Modena	Emilia-Romagna
Italy	Ospedale San Gerardo	Monza	Lombardia
Italy	AOU di Padova	Padova	Veneto
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	Emilia-Romagna
Italy	A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore	Pesaro	Marche
Italy	AUSL di Piacenza - Palazzine Medicine Specialistiche	Piacenza	Emilia-Romagna
Italy	Dipartimento Oncoematologico - AUSL della Romagna	Ravenna	Emilia-Romagna
Italy	Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"	Reggio Calabria	Calabria
Italy	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia	Emilia-Romagna
Italy	Ospedale Infermi Rimini	Rimini	Emilia-Romagna
Italy	A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"	Roma	Lazio
Italy	Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Puglia
Italy	A.O.U. Città della Salute e della Scienza - Presidio Molinette	Torino	Piemonte
Italy	A.O.U. Integrata di Udine	Udine	Friuli-Venezia Giulia
Italy	A.O.U. Integrata Verona - Borgo Roma	Verona	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Thrombosis	To assess the incidence of thrombotic events on PV patients	6 years
Secondary	Haemorrhages	To assess the incidence of haemorrhagic events on PV patients	6 years
Secondary	Therapies	To assess the use of high-cost therapies	6 years
Secondary	Therapies Toxicity	To assess the toxicity of therapies	6 years
Secondary	Therapies Efficacy	To assess the effects of therapies	6 years
Secondary	Development of second neoplasms	To assess the incidence of second malignancies	6 years
Secondary	Evolution to acute leukemias	To assess the incidence of acute leukaemias	6 years