PV-ARC: Clinical and Laboratory Characteristics of Polycythemia Vera

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Recruiting

CT.gov ID

NCT06134102

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

45.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Clinical and Laboratory Characteristics of Polycythemia Vera

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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

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 [6 years]
To assess the use of high-cost therapies
Therapies Toxicity [6 years]
To assess the toxicity of therapies
Therapies Efficacy [6 years]
To assess the effects of therapies
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"	Reggio Calabria	Calabria	Italy	89124
2	IRCCS Policlinico Sant'Orsola	Bologna	Emilia Romagna	Italy	40138
3	Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna	Ferrara	Emilia-Romagna	Italy	44124
4	Policlinico di Modena	Modena	Emilia-Romagna	Italy	41125
5	Azienda Ospedaliero-Universitaria di Parma	Parma	Emilia-Romagna	Italy	43126
6	AUSL di Piacenza - Palazzine Medicine Specialistiche	Piacenza	Emilia-Romagna	Italy	29121
7	Dipartimento Oncoematologico - AUSL della Romagna	Ravenna	Emilia-Romagna	Italy	48121
8	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia	Emilia-Romagna	Italy	42123
9	Ospedale Infermi Rimini	Rimini	Emilia-Romagna	Italy	47923
10	A.O.U. Integrata di Udine	Udine	Friuli-Venezia Giulia	Italy	33100
11	A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"	Roma	Lazio	Italy	00161
12	IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST	Genova	Liguria	Italy	16132
13	IRCCS per l'oncologia -Ospedale Policlinico "San Martino"	Genova	Liguria	Italy	16132
14	ASST Spedali Civili di Brescia	Brescia	Lombardia	Italy	25123
15	Ospedale San Gerardo	Monza	Lombardia	Italy	20900
16	A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore	Pesaro	Marche	Italy	61122
17	A.O.U. Città della Salute e della Scienza - Presidio Molinette	Torino	Piemonte	Italy	10126
18	Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Puglia	Italy	71013
19	Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari	Cagliari	Sardegna	Italy	09131
20	A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto	Catania	Sicilia	Italy	95124
21	AOU di Padova	Padova	Veneto	Italy	35128
22	A.O.U. Integrata Verona - Borgo Roma	Verona	Veneto	Italy	37134

Sponsors and Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Azienda Ospedaliero-Universitaria di Bologna

ClinicalTrials.gov Identifier:

NCT06134102

Other Study ID Numbers:

483/2018/Oss/AOUBo

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycythemia Vera

Polycythemia

Study Results

No Results Posted as of Nov 18, 2023