NCT02953704

Brief Summary

The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,469

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
2 countries

116 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 31, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

5.2 years

First QC Date

November 1, 2016

Last Update Submit

May 11, 2022

Conditions

Keywords

Myelofibrosisessential thrombocythemiaclinical characteristicsdisease burdenpatient-reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients

    Approximately every 6 months through end of study, up to approximately 36 months

Secondary Outcomes (9)

  • Description of patterns of treatment, therapies, and clinical management

    Approximately every 3-6 months through end of study, up to at least 36 months

  • Description of disease progression over time

    Approximately every 3-6 months through end of study, up to at least 36 months

  • Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time

    Approximately every 3-6 months through end of study, up to at least 36 months

  • Description of the comorbidities associated with disease and progression

    Approximately every 3-6 months through end of study, up to at least 36 months

  • Description of changes in patient-reported symptoms and quality of life (QOL)

    Approximately every 3-6 months through end of study, up to at least 36 months

  • +4 more secondary outcomes

Study Arms (2)

Myelofibrosis Cohort

Patients will be categorized as low-risk using Dynamic International Prognostic Scoring System (DIPSS) risk OR intermediate-1 risk by DIPSS by reason of age alone.

Essential Thrombocythemia Cohort

Patients will be age ≥ 60 years OR have history of thromboembolic events OR currently receiving ET-directed therapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be enrolled from up to 250 community and academic centers across the United States.

You may qualify if:

  • MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.
  • ET cohort: Diagnosis of ET and age ≥ 60 years OR history of thromboembolic events OR currently receiving ET-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc).
  • 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 MF or ET.

You may not qualify if:

  • Individuals who are participating in blinded investigational drug studies.
  • Individuals who are participating in Incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit.
  • Life expectancy ≤ 6 months.
  • Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (116)

Unknown Facility

Huntsville, Alabama, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Berkeley, California, United States

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Highland, California, United States

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Long Beach, California, United States

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Oceanside, California, United States

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Palo Alto, California, United States

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Santa Rosa, 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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Middletown, 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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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Thomasville, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Harvey, Illinois, United States

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Maywood, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Skokie, Illinois, United States

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Anderson, Indiana, United States

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Avon, Indiana, United States

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Indianapolis, Indiana, United States

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Terre Haute, Indiana, United States

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Ames, Iowa, United States

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Topeka, Kansas, United States

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Westwood, Kansas, United States

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Danville, Kentucky, United States

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Mount Sterling, Kentucky, United States

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Paducah, Kentucky, United States

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Alexandria, Louisiana, United States

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Covington, Louisiana, United States

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Marrero, 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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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Lansing, Michigan, United States

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Jackson, Minnesota, United States

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Lansing, Minnesota, United States

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Bolivar, Missouri, United States

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Cape Girardeau, Missouri, United States

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Jefferson 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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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, 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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Florham Park, New Jersey, United States

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Morristown, New Jersey, United States

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Paramus, New Jersey, United States

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Albany, New York, United States

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Brooklyn, 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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New York, 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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Boone, North Carolina, United States

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Charlotte, 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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Hendersonville, North Carolina, 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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Toledo, Ohio, United States

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Tualatin, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Gettysburg, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Lancaster, South Carolina, United States

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Spartanburg, South Carolina, United States

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Watertown, South Dakota, United States

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Jackson, Tennessee, United States

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Amarillo, Texas, United States

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Arlington, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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McKinney, Texas, United States

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Mesquite, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Bristol, Virginia, United States

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Seattle, Washington, United States

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Yakima, Washington, United States

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Martinsburg, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Bayamón, Puerto Rico

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Ponce, Puerto Rico

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Related Publications (3)

  • Ritchie E, Al-Janadi A, Kessler C, Scherber R, Kalafut T, Ren H, Mesa R. Patient-reported outcomes of patients with myelofibrosis or essential thrombocythemia enrolled in the MOST study. Leuk Lymphoma. 2022 Dec;63(13):3138-3153. doi: 10.1080/10428194.2022.2113531. Epub 2022 Oct 7.

  • Gerds AT, Lyons RM, Colucci P, Kalafut P, Paranagama D, Verstovsek S. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Myelofibrosis Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):e532-e540. doi: 10.1016/j.clml.2022.02.001. Epub 2022 Feb 8.

  • Yacoub A, Lyons R, Verstovsek S, Shao R, Chu DT, Agrawal A, Sivaraman S, Colucci P, Paranagama D, Mascarenhas J. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Essential Thrombocythemia Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2021 Jul;21(7):461-469. doi: 10.1016/j.clml.2021.02.011. Epub 2021 Mar 1.

MeSH Terms

Conditions

Myeloproliferative DisordersPrimary MyelofibrosisThrombocythemia, Essential

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Officials

  • Robyn M. Scherber, MD, MPH

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 3, 2016

Study Start

December 31, 2016

Primary Completion

March 29, 2022

Study Completion

March 29, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations