A Study to Better Understand the Diagnosis and Treatment of Polycythaemia Vera

NCT07868081 | Not Yet Recruiting

• 2 other identifiers: TAK-121-5004MACS-2026-020602
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  At completion of the approximately 30-minute survey session (up to 10 months)

Secondary Outcomes (4)

• Percentage of Physicians Reporting Use of Diagnostic Procedures and Treatment Modalities Used for PV Management

  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

  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

  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

  At completion of the approximately 30-minute survey session (up to 10 months)

Study Arms (1)

Physician Survey

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

Interventions

No Intervention OTHER

No intervention will be administered in this study.

Physician Survey

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Board-certified or practicing hematology specialists actively managing PV patients.
• Currently practicing in a hospital or clinic setting in the Kingdom of Saudi Arabia or Ukraine or Türkiye.
• Minimum of 3 years of experience in the management of myeloproliferative neoplasms and/or hematological malignancies. Actively managing a minimum number of PV patients, defined as either:
• Has managed at least 10 patients with PV during the past 3 to 5 years, or at least 3 to 5 patients with PV during the past 12 months.
• Willing and able to provide informed consent and participate in a standardized survey and vignette assessment in a language in which the approved study materials are available, including English, Turkish, or Ukrainian, as applicable to the participating country.

You may not qualify if:

• Physicians not currently involved in the diagnosis or management of PV patients.
• Medical trainees, residents, or fellows not yet board-certified or independently practicing.
• Practicing outside of KSA or Ukraine or Türkiye.
• Unwilling or unable to provide informed consent or complete the study procedures.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.