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Clinical and Laboratory Characteristics of Polycythemia Vera

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06134102
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Polycythemia Vera
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Reggio Calabria, Calabria, Italy

Status

Recruiting

Address

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Reggio Calabria, Calabria, 89124

Site Contact

Bruno Martino, MD

[email protected]

+39 0965397195

IRCCS Policlinico Sant'Orsola, Bologna, Emilia Romagna, Italy

Status

Recruiting

Address

IRCCS Policlinico Sant'Orsola

Bologna, Emilia Romagna, 40138

Site Contact

Francesca Palandri, MD, PhD

[email protected]

+390512143044

Ferrara, Emilia-Romagna, Italy

Status

Recruiting

Address

Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna

Ferrara, Emilia-Romagna, 44124

Site Contact

Francesco Cavazzini, MD

[email protected]

+39 0532236987

Policlinico di Modena, Modena, Emilia-Romagna, Italy

Status

Recruiting

Address

Policlinico di Modena

Modena, Emilia-Romagna, 41125

Site Contact

Monica Maccaferri, MD

[email protected]

+39 0594223200

Parma, Emilia-Romagna, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria di Parma

Parma, Emilia-Romagna, 43126

Site Contact

Monica Crugnola, MD

[email protected]

+39 0521704749

Piacenza, Emilia-Romagna, Italy

Status

Recruiting

Address

AUSL di Piacenza - Palazzine Medicine Specialistiche

Piacenza, Emilia-Romagna, 29121

Site Contact

Costanza Bosi, MD

[email protected]

+39 0523303728

Ravenna, Emilia-Romagna, Italy

Status

Recruiting

Address

Dipartimento Oncoematologico - AUSL della Romagna

Ravenna, Emilia-Romagna, 48121

Site Contact

Francesco Lanza, MD

[email protected]

+39 0544285752

Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Emilia-Romagna, Italy

Status

Recruiting

Address

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Emilia-Romagna, 42123

Site Contact

Alessia Tieghi, MD

[email protected]

+39 0522296623

Ospedale Infermi Rimini, Rimini, Emilia-Romagna, Italy

Status

Recruiting

Address

Ospedale Infermi Rimini

Rimini, Emilia-Romagna, 47923

Site Contact

Francesco Rotondo, MD

[email protected]

+39 0541705423

A.O.U. Integrata di Udine, Udine, Friuli-Venezia Giulia, Italy

Status

Recruiting

Address

A.O.U. Integrata di Udine

Udine, Friuli-Venezia Giulia, 33100

Site Contact

Mario Tiribelli, MD

[email protected]

+39 0432 559666

Roma, Lazio, Italy

Status

Recruiting

Address

A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"

Roma, Lazio, 00161

Site Contact

Massimo Breccia, MD

[email protected]

+39 0685795440

Genova, Liguria, Italy

Status

Recruiting

Address

IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST

Genova, Liguria, 16132

Site Contact

Roberto Lemoli, MD

[email protected]

+39 0103538978

Genova, Liguria, Italy

Status

Recruiting

Address

IRCCS per l'oncologia -Ospedale Policlinico "San Martino"

Genova, Liguria, 16132

Site Contact

Adalberto Ibatici, MD

[email protected]

+39 0105554311

ASST Spedali Civili di Brescia, Brescia, Lombardia, Italy

Status

Recruiting

Address

ASST Spedali Civili di Brescia

Brescia, Lombardia, 25123

Site Contact

Nicola Polverelli, MD

[email protected]

+39 0303996811

Ospedale San Gerardo, Monza, Lombardia, Italy

Status

Recruiting

Address

Ospedale San Gerardo

Monza, Lombardia, 20900

Site Contact

Elena Elli, MD

[email protected]

+39 0392339859

Pesaro, Marche, Italy

Status

Recruiting

Address

A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore

Pesaro, Marche, 61122

Site Contact

Alessandro Isidori, MD

[email protected]

+39 0721364022

Torino, Piemonte, Italy

Status

Recruiting

Address

A.O.U. Città della Salute e della Scienza - Presidio Molinette

Torino, Piemonte, 10126

Site Contact

Giulia Benevolo, MD

[email protected]

+39 0116336177

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Puglia, Italy

Status

Recruiting

Address

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Puglia, 71013

Site Contact

Nicola Cascavilla, MD

[email protected]

+39 0882410022

Cagliari, Sardegna, Italy

Status

Recruiting

Address

Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari

Cagliari, Sardegna, 09131

Site Contact

Giovanni Caocci, MD

[email protected]

+39 070 52965520

Catania, Sicilia, Italy

Status

Recruiting

Address

A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto

Catania, Sicilia, 95124

Site Contact

Giuseppe Palumbo, MD

[email protected]

+39 3283423820

AOU di Padova, Padova, Veneto, Italy

Status

Recruiting

Address

AOU di Padova

Padova, Veneto, 35128

Site Contact

Gianni Binotto, MD

[email protected]

+39 0498217091

A.O.U. Integrata Verona - Borgo Roma, Verona, Veneto, Italy

Status

Recruiting

Address

A.O.U. Integrata Verona - Borgo Roma

Verona, Veneto, 37134

Site Contact

Massimiliano Bonifacio, MD

[email protected]

+ 39 0458124443