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Completed

NCT Number: NCT02252159

Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayamón, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Diagnosis of Polycythemia Vera (PV)
  • Willing and able to provide written informed consent
  • Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
  • Under the supervision of a physician for the current care of PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide

Exclusion criteria

  • Participation in an active clinical trial in which the study treatment is blinded
  • Life expectancy <6 months
  • Diagnosis of myelofibrosis (MF) [including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)]
  • Diagnosis of secondary Acute Myeloid Leukemia (AML)
  • Diagnosis of Myelodysplastic Syndrome (MDS)
  • History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months
  • Splenectomy

Treatment and study plan

Primary outcomes

  1. Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments

    Time frame: Every 3 months for approximately 36 months

  2. Incidence (frequency) of disease progression

    Time frame: Every 3 months for approximately 36 months

  3. Incidence (frequency) of healthcare resources utilization

    Time frame: Every 3 months for approximately 36 months

    Healthcare resources were defined as a. Medical visits (including Office visits, ER visits, and hospitalizations), b. phlebotomy (PHL) procedures and c. prescriptions (including PV-related prescriptions, PV-related over-the-counter (OTC) medications, and prescription medications for co-morbid conditions).

  4. Incidence (frequency) of complications due to PV

    Time frame: Every 3 months for approximately 36 months

  5. Incidence (frequency) and description of PV-related symptoms

    Time frame: Every 3 months for approximately 36 months

Secondary outcomes

  1. Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)

    Time frame: Baseline through end of study. Approximately 36 months

  2. Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms

    Time frame: Every 3 months for approximately 36 months

    The MPN-SAF TSS is a validated 10-item instrument that efficiently assesses the prevalence and severity of PV symptoms in both clinical practice and trial settings. Higher scores indicate more severe symptoms and greater inactivity with a possible total score range of 0-100.

  3. Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment

    Time frame: Every 3 months for approximately 36 months

    WPAI-SHP is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and outside of it. All outcomes are presented as a proportion, with 0% representing minimal/no impairment and 100% representing maximal impairment or productivity loss.

  4. European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)

    Time frame: Every 3 months for approximately 36 months

  5. Caregiver burden

    Time frame: Every 3 months for approximately 36 months

    The amount of health care received by a paid healthcare worker or by an unpaid caregiver

  6. Burden of phlebotomy (PHL)

    Time frame: Every 3 months for approximately 36 months

    A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2014
Registry last updated
Apr 26, 2021

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.

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