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Clinical and Laboratory Characteristics of Polycythemia Vera

Clinical and Laboratory Characteristics of Polycythemia Vera

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06134102
Acronym
PV-ARC
Enrollment
1150
Registered
2023-11-18
Start date
2019-01-01
Completion date
2023-12-31
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera

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

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Long-term survival6 yearsTo determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival

Secondary

MeasureTime frameDescription
Development of second neoplasms6 yearsTo assess the incidence of second malignancies
Evolution to acute leukemias6 yearsTo assess the incidence of acute leukaemias
Thrombosis6 yearsTo assess the incidence of thrombotic events on PV patients
Therapies Efficacy6 yearsTo assess the effects of therapies
Therapies6 yearsTo assess the use of high-cost therapies
Therapies Toxicity6 yearsTo assess the toxicity of therapies
Haemorrhages6 yearsTo assess the incidence of haemorrhagic events on PV patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026