An observational study in Polycythemia Vera, sponsored by Takeda. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Takeda · Observational
PV is a rare, long-term blood cancer that causes the body to make too many blood cells. This can make the blood thicker than normal and the risk of blood clots higher. People with PV often experience symptoms that can affect their daily lives. Understanding how doctors diagnose and treat PV in everyday medical practice in a certain country can help find the differences in knowledge, diagnosis, and treatment of PV across countries.
This study will not review or collect data from actual people with PV. It will collect information on the diagnosis and treatment of PV using a standard set of questions on and examples of fictional (unreal) people with PV. This is called clinical vignette. The study will ask doctors from several countries to complete this survey.
The main aim of this study is to better understand how well doctors know about and diagnose PV and how they treat PV in certain countries.
Other aims are to better understand how PV is managed and treated in everyday medical practice across countries. This includes which treatment people with PV receive once they are diagnosed and how access to medicines and healthcare services and other factors affects a doctor's treatment decisions for PV.
This study is a non-interventional, cross-sectional physician survey study employing a Knowledge, Attitudes and Practices (KAP) framework and standardized Polycythemia Vera clinical vignettes. Data are collected through a single interviewer-led session with practicing hematologists and hemato-oncologists. The study evaluates physician diagnostic and treatment decision-making patterns and does not involve patient enrollment, patient-level data collection, treatment assignment, or longitudinal follow-up.
238 studies on the registry are indexed under Polycythemia Vera; 57 are open to participants now.
This study's planned enrollment of 90 is below the median of 236 across 46 observational studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Licensed hematologists and hemato-oncologists who are board-certified or independently practicing and actively involved in diagnosing or managing patients with PV will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
This study is based on physician responses to standardized clinical vignettes. Therefore, eligibility applies to participating physicians:
Inclusion Criteria:
Exclusion Criteria:
Eligible hematologists and hemato-oncologists will participate in a single survey session lasting approximately 30 minutes. The session will use standardized PV clinical vignettes and a combination of open and closed-ended questions to assess physicians' KAP and clinical decision making. All data will be collected through audio-recorded interviews (where applicable) and/or typed narrative entries in a secure online platform. No clinical intervention will be administered, and no follow-up will be conducted.
Other: No Intervention
No intervention will be administered in this study.
Percentage of Participating Physicians Correctly Identifying the Prespecified Diagnostic Criteria and Risk-Classification Factors for PV in Standardized Clinical Vignettes
For each prespecified diagnostic criterion and risk-classification factor, the percentage of participating physicians selecting the protocol-defined correct response will be reported.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Physician Responses Regarding Early Cytoreductive Treatment in PV
The number of participating physicians selecting each response category for the statement 'Early cytoreductive therapy is underutilized in PV management in my region' will be reported using a 5-point Likert agreement scale ranging from 1, 'Strongly disagree,' to 5, 'Strongly agree.' Higher scores indicate greater agreement with the statement. Treatment choices made in the standardized PV clinical vignettes will also be summarized descriptively.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Concordance of Physician-Reported Diagnostic and Treatment Decisions With Prespecified PV Guideline-Based Criteria
For each applicable survey or vignette decision, the number of participating physicians whose response is concordant with the protocol-defined guideline-based criterion will be reported.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Self-Reported Rate of Adherence to International Guidelines in Diagnostic and Therapeutic Decisions
For each guideline category, the number of participating physicians reporting 'Always,' 'Often,' or 'Rarely' will be summarized. The international guideline most commonly used will also be reported.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Distribution of Physician-Reported Phlebotomy Use and Cytoreductive Treatment in Current PV Management
The distribution of the estimated percentage of physicians' patients currently managed with phlebotomy alone, phlebotomy plus cytoreductive therapy, ruxolitinib, or other therapies will be summarized.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Number of Physicians by Reported HCT Monitoring Frequencies and HCT Thresholds for Treatment Escalation
HCT monitoring intervals will be summarized separately for low- and high-risk PV. Physician-reported HCT thresholds for treatment escalation will be summarized descriptively.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Reporting Use of Diagnostic Procedures and Treatment Modalities Used for PV Management
The percentage of participating physicians reporting use of each prespecified diagnostic procedure and treatment modality, including phlebotomy, aspirin, cytoreductive treatment, and individual treatment agents, will be reported. For each prespecified diagnostic or monitoring tool, the number and percentage of physicians reporting 'Always,' 'Often,' or 'Rarely' will be reported separately for initial diagnosis and ongoing monitoring.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Reporting Factors Influencing Clinical Decision-Making in PV Management
The percentage of participating physicians selecting each prespecified factor, including physician experience, resource limitations, patient characteristics, treatment preferences, and access-related considerations, as most important in their decision to change PV treatment will be reported.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Selecting Each Treatment-Management Option in low- and High-Risk PV Clinical Vignettes
Percentage of physicians selecting each prespecified classification and treatment-management option in response to low- and high-risk PV clinical vignettes will be reported. Responses will be descriptively aggregated to summarize commonly reported sequences of treatment without ranking treatment sequences, identifying an optimal sequence, or making causal inferences.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
Percentage of Physicians Reporting Systemic Barriers to Optimal PV Care and Their Perceived Impact
For each prespecified barrier to early cytoreductive therapy, the percentage of physicians rating its impact as high, moderate, or low will be reported. The barriers selected among the top three barriers to optimal PV care will be summarized separately.
Time frame: At completion of the approximately 30-minute survey session (up to 10 months)
No study locations are listed for this record.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized or de-identified data, as applicable, (to protect participating physicians' privacy in accordance with applicable laws and regulations, together) with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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