Skip to main content
OpenTrials
Completed

NCT Number: NCT06134102

Clinical and Laboratory Characteristics of Polycythemia Vera

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycythemia Vera Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Thrombosis

    Time frame: 6 years

    To assess the incidence of thrombotic events on PV patients

  2. Haemorrhages

    Time frame: 6 years

    To assess the incidence of haemorrhagic events on PV patients

  3. Therapies

    Time frame: 6 years

    To assess the use of high-cost therapies

  4. Therapies Toxicity

    Time frame: 6 years

    To assess the toxicity of therapies

  5. Therapies Efficacy

    Time frame: 6 years

    To assess the effects of therapies

  6. Development of second neoplasms

    Time frame: 6 years

    To assess the incidence of second malignancies

  7. Evolution to acute leukemias

    Time frame: 6 years

    To assess the incidence of acute leukaemias

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PV-ARC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.