Polycythemia VeraPV-ARCNCT06134102
Clinical and Laboratory Characteristics of Polycythemia Vera
An observational study of Polycythemia Vera, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 22 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- How many people
- 1,150 participants
- Where
- 22 sitesItaly
- Study dates
- 1 Jan 2019to 31 Dec 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with PV according to WHO 2017 criteria,
- Obtaining informed consent for data collection and processing
Who cannot join
- None
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Italy22 sites
IRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, 40138
ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
Cagliari, Sardinia, 09131
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
Catania, Sicily, 95124
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44124
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
Genoa, Liguria, 16132
IRCCS per l'oncologia -Ospedale Policlinico "San Martino"
Genoa, Liguria, 16132
Policlinico di Modena
Modena, Emilia-Romagna, 41125
Ospedale San Gerardo
Monza, Lombardy, 20900
AOU di Padova
Padova, Veneto, 35128
Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, 43126
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
Pesaro, The Marches, 61122
AUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, 29121
Dipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, 48121
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, 89124
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Emilia-Romagna, 42123
Ospedale Infermi Rimini
Rimini, Emilia-Romagna, 47923
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, Lazio, 00161
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Apulia, 71013
A.O.U. Città della Salute e della Scienza - Presidio Molinette
Turin, Piedmont, 10126
A.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100
A.O.U. Integrata Verona - Borgo Roma
Verona, Veneto, 37134
About this study
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
Read the 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.
- Conditions
- Polycythemia Vera
- Medical subject headings
- Polycythemia Vera
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival
To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival
Measured: 6 years
Secondary outcomes (7)
Thrombosis
To assess the incidence of thrombotic events on PV patients
Measured: 6 years
Haemorrhages
To assess the incidence of haemorrhagic events on PV patients
Measured: 6 years
Therapies
To assess the use of high-cost therapies
Measured: 6 years
Therapies Toxicity
To assess the toxicity of therapies
Measured: 6 years
Therapies Efficacy
To assess the effects of therapies
Measured: 6 years
Development of second neoplasms
To assess the incidence of second malignancies
Measured: 6 years
Evolution to acute leukemias
To assess the incidence of acute leukaemias
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,150 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134102
- Sponsor's protocol ID
- 483/2018/Oss/AOUBo
- Acronym
- PV-ARC
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palandri F, Dedola A, Caocci G, Rossi E, Elli EM, Sartor C, Latagliata R, Pugliese N, Morsia E, Binotto G, Mendicino F, Tieghi A, Benevolo G, Martino B, D'Addio A, Tiribelli M, Cilloni D, Crugnola M, Cavalca F, Scalzulli E, Lanza F, Pane F, Palumbo GA, Heidel FH, De Stefano V, Breccia M, Branzanti F. A dynamic prognostic model for polycythemia vera long-term outcomes in patients treated with ruxolitinib. Blood Adv. 2026 Aug 11;10(15):5469-5479. doi: 10.1182/bloodadvances.2026020255.
PubMed 42275537
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Characteristics of Polycythemia Vera
- ClinicalTrials.gov ID
- NCT06134102
- Acronym / sponsor ID
- PV-ARC / 483/2018/Oss/AOUBo
- Conditions
- Polycythemia Vera
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with PV according to WHO 2017 criteria,
- Obtaining informed consent for data collection and processing
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Thrombosis
Time frame: 6 years
Haemorrhages
Time frame: 6 years
Therapies
Time frame: 6 years
Therapies Toxicity
Time frame: 6 years
Therapies Efficacy
Time frame: 6 years
Development of second neoplasms
Time frame: 6 years
Evolution to acute leukemias
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 42275537Palandri F, Dedola A, Caocci G, Rossi E, Elli EM, Sartor C, Latagliata R, Pugliese N, Morsia E, Binotto G, Mendicino F, Tieghi A, Benevolo G, Martino B, D'Addio A, Tiribelli M, Cilloni D, Crugnola M, Cavalca F, Scalzulli E, Lanza F, Pane F, Palumbo GA, Heidel FH, De Stefano V, Breccia M, Branzanti F. A dynamic prognostic model for polycythemia vera long-term outcomes in patients treated with ruxolitinib. Blood Adv. 2026 Aug 11;10(15):5469-5479. doi: 10.1182/bloodadvances.2026020255.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 22 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term survival (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.