Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-27 @ 8:25 AM
Study NCT ID:
NCT02953704
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2016-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1469}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients', 'timeFrame': 'Approximately every 6 months through end of study, up to approximately 36 months'}], 'secondaryOutcomes': [{'measure': 'Description of patterns of treatment, therapies, and clinical management', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of disease progression over time', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of the comorbidities associated with disease and progression', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of changes in patient-reported symptoms and quality of life (QOL)', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of the rate and time to leukemic transformation', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of rate of all-cause mortality and aggregate causes of mortality', 'timeFrame': 'Approximately every 3-6 months through end of study, up to at least 36 months'}, {'measure': 'Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only)', 'timeFrame': 'At screening'}, {'measure': 'Description of time to first disease-related intervention or first progression event during the period of observation (MF patients only)', 'timeFrame': 'Baseline to end of study, up to 36 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myelofibrosis', 'essential thrombocythemia', 'clinical characteristics', 'disease burden', 'patient-reported outcomes'], 'conditions': ['MPN (Myeloproliferative Neoplasms)']}, 'referencesModule': {'references': [{'pmid': '36205505', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35256316', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33839074', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be enrolled from up to 250 community and academic centers across the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.\n* 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).\n* Willing and able to provide written informed consent.\n* Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel.\n* Under the supervision of a physician for the current care of MF or ET.\n\nExclusion Criteria:\n\n* Individuals who are participating in blinded investigational drug studies.\n* 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.\n* Life expectancy ≤ 6 months.\n* Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.'}, 'identificationModule': {'nctId': 'NCT02953704', 'briefTitle': 'Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Prospective, Longitudinal, Non-Interventional Study of Disease Burden and Treatment of Patients With Low-Risk Myelofibrosis (MF) or High-Risk Essential Thrombocythemia (ET) or ET Patients Receiving ET-Directed Therapy', 'orgStudyIdInfo': {'id': 'INCB-MA-MF-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myelofibrosis Cohort', 'description': '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.'}, {'label': 'Essential Thrombocythemia Cohort', 'description': 'Patients will be age ≥ 60 years OR have history of thromboembolic events OR currently receiving ET-directed therapy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tucson', 'state': 'Arizona', 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