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

Status
Active
Cancer Type
Hematologic Malignancies
Trial Phase
Phase IV
Eligibility
Adult, Male and Female
Study Type
NCD ID
NCT02252159
Protocol IDs
INCB-MA-PV-401 (primary)
Study Sponsor
Incyte Corporation
NCI Full Details

Summary

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.

Objectives

 

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence (frequency) of disease progression [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]
  • Incidence (frequency) of healthcare resources utilization [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]
    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).
  • Incidence (frequency) of complications due to PV [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]
  • Incidence (frequency) and description of PV-related symptoms [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]

 

Secondary Outcome Measures:
  • Incidence (frequency) of adverse events (for those patients on active therapies, including PHL) [ Time Frame: Baseline through end of study. Approximately 36 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • Caregiver burden [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]
    The amount of health care received by a paid healthcare worker or by an unpaid caregiver
  • Burden of phlebotomy (PHL) [ Time Frame: Every 3 months for approximately 36 months ] [ Designated as safety issue: No ]
    A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.


Biospecimen Retention:   Samples With DNA

Blood sample(s), two vials, one with heparin, another with ethylenediaminetetraacetic acid (EDTA) will be collected at enrollment and then annually thereafter until the end of study for serum analysis of proteins and assessment of allele burden and mutations.

 

Estimated Enrollment: 2000
Study Start Date: July 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
 

 

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