Clinical trial NCT02252159: Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MPN (Myeloproliferative Neoplasms)
Keywords: Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 2544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
timeFrame: Every 3 months for approximately 36 months
measure: Incidence (frequency) of disease progression
timeFrame: Every 3 months for approximately 36 months
measure: Incidence (frequency) of healthcare resources utilization
timeFrame: Every 3 months for approximately 36 months
measure: Incidence (frequency) of complications due to PV
timeFrame: Every 3 months for approximately 36 months
measure: Incidence (frequency) and description of PV-related symptoms
timeFrame: Every 3 months for approximately 36 months
Secondary outcomes:
measure: Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)
timeFrame: Baseline through end of study. Approximately 36 months
measure: Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms
timeFrame: Every 3 months for approximately 36 months
measure: Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment
timeFrame: Every 3 months for approximately 36 months
measure: European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)
timeFrame: Every 3 months for approximately 36 months
measure: Caregiver burden
timeFrame: Every 3 months for approximately 36 months
measure: Burden of phlebotomy (PHL)
timeFrame: Every 3 months for approximately 36 months
Other outcomes:
Locations:
city: Green Valley
country: United States
state: Arizona
city: Safford
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Yuma
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Stuttgart
country: United States
state: Arkansas
city: Berkeley
country: United States
state: California
city: Burbank
country: United States
state: California
city: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Highland
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Riverside
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Vallejo
country: United States
state: California
city: West Hills
country: United States
state: California
city: Whittier
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Pueblo
country: United States
state: Colorado
city: Middletown
country: United States
state: Connecticut
city: Norwich
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Santa Rosa Beach
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Austell
country: United States
state: Georgia
city: Cartersville
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Douglasville
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Thomasville
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Post Falls
country: United States
state: Idaho
city: Berwyn
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Danville
country: United States
state: Illinois
city: Decatur
country: United States
state: Illinois
city: Effingham
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Harvey
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Kewanee
country: United States
state: Illinois
city: Macomb
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Morris
country: United States
state: Illinois
city: New Lenox
country: United States
state: Illinois
city: Normal
country: United States
state: Illinois
city: Ottawa
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Pekin
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Peru
country: United States
state: Illinois
city: Princeton
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Anderson
country: United States
state: Indiana
city: Columbus
country: United States
state: Indiana
city: Crown Point
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Marion
country: United States
state: Indiana
city: Mooresville
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Cedar Rapids
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Mason City
country: United States
state: Iowa
city: Sioux City
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Ashland
country: United States
state: Kentucky
city: Danville
country: United States
state: Kentucky
city: Hazard
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Mount Sterling
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Richmond
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Baton Rouge
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Rockport
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Clinton
country: United States
state: Maryland
city: Cumberland
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Fairhaven
country: United States
state: Massachusetts
city: Lawrence
country: United States
state: Massachusetts
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Battle Creek
country: United States
state: Michigan
city: Brighton
country: United States
state: Michigan
city: Canton
country: United States
state: Michigan
city: Chelsea
country: United States
state: Michigan
city: Dearborn
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Pontiac
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Saint Cloud
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Bolivar
country: United States
state: Missouri
city: Cape Girardeau
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Kalispell
country: United States
state: Montana
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Dover
country: United States
state: New Hampshire
city: Portsmouth
country: United States
state: New Hampshire
city: Brick
country: United States
state: New Jersey
city: East Orange
country: United States
state: New Jersey
city: Edison
country: United States
state: New Jersey
city: Flemington
country: United States
state: New Jersey
city: Hackettstown
country: United States
state: New Jersey
city: Paramus
country: United States
state: New Jersey
city: Somerville
country: United States
state: New Jersey
city: Sparta
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Farmington
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Binghamton
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Cooperstown
country: United States
state: New York
city: Corning
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Elmira
country: United States
state: New York
city: Herkimer
country: United States
state: New York
city: Ithaca
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Oneonta
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Albemarle
country: United States
state: North Carolina
city: Boone
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Clayton
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Hendersonville
country: United States
state: North Carolina
city: Henderson
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Lincolnton
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Smithfield
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dover
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Massillon
country: United States
state: Ohio
city: Mount Vernon
country: United States
state: Ohio
city: Oregon
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: West Chester
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Beaverton
country: United States
state: Oregon
city: Corvallis
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Broomall
country: United States
state: Pennsylvania
city: Drexel Hill
country: United States
state: Pennsylvania
city: Easton
country: United States
state: Pennsylvania
city: Gettysburg
country: United States
state: Pennsylvania
city: Hanover
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Kittanning
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Quakertown
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Wellsboro
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Hilton Head Island
country: United States
state: South Carolina
city: Murrells Inlet
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Sioux Falls
country: United States
state: South Dakota
city: Watertown
country: United States
state: South Dakota
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Athens
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Jacksonville
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Bristol
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Portsmouth
country: United States
state: Virginia
city: Suffolk
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Everett
country: United States
state: Washington
city: Puyallup
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Martinsburg
country: United States
state: West Virginia
city: Green Bay
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Weston
country: United States
state: Wisconsin
city: Bayamon
country: Puerto Rico
city: Ponce
country: Puerto Rico
Study officials:
affiliation: Incyte Corporation
name: Robyn M. Scherber, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Gerds AT, Mesa R, Burke JM, Grunwald MR, Scherber R, Yu J, Hamer-Maansson JE, Oh ST. MPN-103 A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera: Analysis of Data From the REVEAL Study. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S326. doi: 10.1016/S2152-2650(22)01437-9.
citation: Zwicker 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.
citation: Grunwald 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.
citation: Mesa 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.