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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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