Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
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|ClinicalTrials.gov Identifier: NCT02252159|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : June 18, 2018
|Condition or disease|
|MPN (Myeloproliferative Neoplasms)|
|Study Type :||Observational|
|Actual Enrollment :||2544 participants|
|Official Title:||Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with:
(*Unless patient has a history of intolerance or clinical resistance/ refractoriness to hydroxyurea [HU] (as assessed by the treating physician) - in which case, s/he belongs to Cohort B)
Patients with clinically overt PV, with one or more of the following disease characteristics:
- 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 ]
- Incidence (frequency) of disease progression [ Time Frame: Every 3 months for approximately 36 months ]
- 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).
- Incidence (frequency) of complications due to PV [ Time Frame: Every 3 months for approximately 36 months ]
- Incidence (frequency) and description of PV-related symptoms [ Time Frame: Every 3 months for approximately 36 months ]
- Incidence (frequency) of adverse events (for those patients on active therapies, including PHL) [ Time Frame: Baseline through end of study. Approximately 36 months ]
- 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.
- 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.
- 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 ]
- 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
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252159
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|Study Director:||Philomena Colucci, DO, MS||Incyte Corporation|