Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
1 other identifier
observational
2,544
2 countries
266
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Longer than P75 for all trials
266 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2014
CompletedFirst Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2019
CompletedApril 26, 2021
April 1, 2021
5 years
September 23, 2014
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
Every 3 months for approximately 36 months
Incidence (frequency) of disease progression
Every 3 months for approximately 36 months
Incidence (frequency) of healthcare resources utilization
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).
Every 3 months for approximately 36 months
Incidence (frequency) of complications due to PV
Every 3 months for approximately 36 months
Incidence (frequency) and description of PV-related symptoms
Every 3 months for approximately 36 months
Secondary Outcomes (6)
Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)
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
Every 3 months for approximately 36 months
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment
Every 3 months for approximately 36 months
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)
Every 3 months for approximately 36 months
Caregiver burden
Every 3 months for approximately 36 months
- +1 more secondary outcomes
Study Arms (2)
Cohort A
Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with: 1. Watchful waiting (with or without aspirin)\*, or 2. Phlebotomy (PHL) alone (with or without aspirin)\* - or 3. HU alone (without concomitant PHL, with or without aspirin). (\*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)
Cohort B
Patients with clinically overt PV, with one or more of the following disease characteristics: 1. Treatment with HU and PHL in combination or 2. Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or 3. A history of thrombosis (venous or arterial) or 4. A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or 5. Presence of documented splenomegaly (clinically assessed by palpation) or 6. Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment) 1. Tiredness 2. Difficulty sleeping 3. Itching 4. Muscle aches and/or bone pain 5. Night sweats 6. Sweats while awake 7. Other
Eligibility Criteria
An adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV will be enrolled. Sites will include both community and academic centers across the United States that are representative of where patients with PV are diagnosed and treated.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (266)
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Green Valley, Arizona, United States
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Safford, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Yuma, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Stuttgart, Arkansas, United States
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Berkeley, California, United States
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Burbank, California, United States
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Corona, California, United States
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Fountain Valley, California, United States
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Highland, California, United States
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Laguna Hills, California, United States
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Los Alamitos, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pismo Beach, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Santa Maria, California, United States
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Santa Rosa, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Vallejo, California, United States
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West Hills, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Pueblo, Colorado, United States
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Middletown, Connecticut, United States
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Norwich, Connecticut, United States
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Stamford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami Lakes, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Santa Rosa Beach, Florida, United States
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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Austell, Georgia, United States
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Cartersville, Georgia, United States
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Columbus, Georgia, United States
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Douglasville, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Rome, Georgia, United States
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Savannah, Georgia, United States
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Thomasville, Georgia, United States
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Boise, Idaho, United States
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Post Falls, Idaho, United States
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Berwyn, Illinois, United States
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Chicago, Illinois, United States
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Danville, Illinois, United States
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Decatur, Illinois, United States
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Effingham, Illinois, United States
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Evanston, Illinois, United States
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Harvey, Illinois, United States
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Joliet, Illinois, United States
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Kewanee, Illinois, United States
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Macomb, Illinois, United States
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Maywood, Illinois, United States
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Morris, Illinois, United States
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New Lenox, Illinois, United States
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Normal, Illinois, United States
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Ottawa, Illinois, United States
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Park Ridge, Illinois, United States
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Pekin, Illinois, United States
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Peoria, Illinois, United States
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Peru, Illinois, United States
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Princeton, Illinois, United States
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Skokie, Illinois, United States
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Springfield, Illinois, United States
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Urbana, Illinois, United States
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Anderson, Indiana, United States
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Columbus, Indiana, United States
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Crown Point, Indiana, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Marion, Indiana, United States
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Mooresville, Indiana, United States
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New Albany, Indiana, United States
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Newburgh, Indiana, United States
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Terre Haute, Indiana, United States
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Cedar Rapids, Iowa, United States
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Iowa City, Iowa, United States
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Mason City, Iowa, United States
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Sioux City, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Ashland, Kentucky, United States
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Danville, Kentucky, United States
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Hazard, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Paducah, Kentucky, United States
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Richmond, Kentucky, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Rockport, Maine, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Clinton, Maryland, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Fairhaven, Massachusetts, United States
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Lawrence, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Battle Creek, Michigan, United States
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Brighton, Michigan, United States
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Canton, Michigan, United States
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Chelsea, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Grand Rapids, Michigan, United States
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Jackson, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Marquette, Michigan, United States
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Pontiac, Michigan, United States
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Saginaw, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Saint Paul, Minnesota, United States
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Bolivar, Missouri, United States
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Cape Girardeau, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Kalispell, Montana, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Dover, New Hampshire, United States
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Portsmouth, New Hampshire, United States
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Brick, New Jersey, United States
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East Orange, New Jersey, United States
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Edison, New Jersey, United States
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Flemington, New Jersey, United States
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Hackettstown, New Jersey, United States
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Paramus, New Jersey, United States
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Somerville, New Jersey, United States
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Sparta, New Jersey, United States
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Vineland, New Jersey, United States
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Farmington, New Mexico, United States
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Albany, New York, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Cooperstown, New York, United States
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Corning, New York, United States
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East Setauket, New York, United States
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Elmira, New York, United States
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Herkimer, New York, United States
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Ithaca, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Oneonta, New York, United States
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Poughkeepsie, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Utica, New York, United States
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Albemarle, North Carolina, United States
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Boone, North Carolina, United States
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Charlotte, North Carolina, United States
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Clayton, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Henderson, North Carolina, United States
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Hendersonville, North Carolina, United States
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Hickory, North Carolina, United States
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Lincolnton, North Carolina, United States
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Shelby, North Carolina, United States
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Smithfield, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dover, Ohio, United States
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Huber Heights, Ohio, United States
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Massillon, Ohio, United States
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Mount Vernon, Ohio, United States
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Oregon, Ohio, United States
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Toledo, Ohio, United States
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West Chester, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Beaverton, Oregon, United States
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Corvallis, Oregon, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Allentown, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Broomall, Pennsylvania, United States
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Drexel Hill, Pennsylvania, United States
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Easton, Pennsylvania, United States
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Gettysburg, Pennsylvania, United States
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Hanover, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Kittanning, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Quakertown, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Wellsboro, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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York, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Charleston, South Carolina, United States
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Hilton Head Island, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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Rock Hill, South Carolina, United States
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Rapid City, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Watertown, South Dakota, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Athens, Texas, United States
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Bryan, Texas, United States
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Corpus Christi, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Jacksonville, Texas, United States
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Plano, Texas, United States
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Richardson, Texas, United States
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Tyler, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Bristol, Virginia, United States
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Chesapeake, Virginia, United States
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Falls Church, Virginia, United States
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Portsmouth, Virginia, United States
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Suffolk, Virginia, United States
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Bellingham, Washington, United States
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Everett, Washington, United States
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Puyallup, Washington, United States
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Seattle, Washington, United States
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Martinsburg, West Virginia, United States
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Green Bay, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Weston, Wisconsin, United States
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Bayamón, Puerto Rico
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Ponce, Puerto Rico
Related Publications (4)
Gerds AT, Mesa R, Burke JM, Grunwald MR, Stein BL, Squier P, Yu J, Hamer-Maansson JE, Oh ST. Association between elevated white blood cell counts and thrombotic events in polycythemia vera: analysis from REVEAL. Blood. 2024 Apr 18;143(16):1646-1655. doi: 10.1182/blood.2023020232.
PMID: 38142448DERIVEDZwicker JI, Paranagama D, Lessen DS, Colucci PM, Grunwald MR. Hemorrhage in patients with polycythemia vera receiving aspirin with an anticoagulant: a prospective, observational study. Haematologica. 2022 May 1;107(5):1106-1110. doi: 10.3324/haematol.2021.279032.
PMID: 34162181DERIVEDGrunwald MR, Burke JM, Kuter DJ, Gerds AT, Stein B, Walshauser MA, Parasuraman S, Colucci P, Paranagama D, Savona MR, Mesa R. Symptom Burden and Blood Counts in Patients With Polycythemia Vera in the United States: An Analysis From the REVEAL Study. Clin Lymphoma Myeloma Leuk. 2019 Sep;19(9):579-584.e1. doi: 10.1016/j.clml.2019.06.001. Epub 2019 Jun 13.
PMID: 31303457DERIVEDMesa R, Boccia RV, Grunwald MR, Oh ST, Colucci P, Paranagama D, Parasuraman S, Stein BL. Patient-Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline): A Prospective Observational Study of Patients With Polycythemia Vera in the United States. Clin Lymphoma Myeloma Leuk. 2018 Sep;18(9):590-596. doi: 10.1016/j.clml.2018.05.020. Epub 2018 May 28.
PMID: 30122202DERIVED
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robyn M. Scherber, MD, MPH
Incyte Corporation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
September 30, 2014
Study Start
July 31, 2014
Primary Completion
August 3, 2019
Study Completion
August 3, 2019
Last Updated
April 26, 2021
Record last verified: 2021-04