Clinical and Laboratory Characteristics of Polycythemia Vera (PV-ARC)

July 17, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term survival
Time Frame: 6 years
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483/2018/Oss/AOUBo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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