Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02252159
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D011086', 'term': 'Polycythemia'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2544}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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).'}, {'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'}], 'secondaryOutcomes': [{'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', 'description': '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.'}, {'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', 'description': '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.'}, {'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', 'description': 'The amount of health care received by a paid healthcare worker or by an unpaid caregiver'}, {'measure': 'Burden of phlebotomy (PHL)', 'timeFrame': 'Every 3 months for approximately 36 months', 'description': 'A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['MPN (Myeloproliferative Neoplasms)']}, 'referencesModule': {'references': [{'pmid': '38142448', 'type': 'DERIVED', 'citation': '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': '34162181', 'type': 'DERIVED', '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.'}, {'pmid': '31303457', 'type': 'DERIVED', '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.'}, {'pmid': '30122202', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.RevealPVStudy.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of Polycythemia Vera (PV)\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 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\n\nExclusion Criteria:\n\n* Participation in an active clinical trial in which the study treatment is blinded\n* Life expectancy \\<6 months\n* Diagnosis of myelofibrosis (MF) \\[including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)\\]\n* Diagnosis of secondary Acute Myeloid Leukemia (AML)\n* Diagnosis of Myelodysplastic Syndrome (MDS)\n* History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months\n* Splenectomy'}, 'identificationModule': {'nctId': 'NCT02252159', 'briefTitle': 'Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices', 'orgStudyIdInfo': {'id': 'INCB-MA-PV-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with:\n\n1. Watchful waiting (with or without aspirin)\\*, or\n2. Phlebotomy (PHL) alone (with or without aspirin)\\* - or\n3. HU alone (without concomitant PHL, with or without aspirin).\n\n(\\*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)'}, {'label': 'Cohort B', 'description': "Patients with clinically overt PV, with one or more of the following disease characteristics:\n\n1. Treatment with HU and PHL in combination or\n2. Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or\n3. A history of thrombosis (venous or arterial) or\n4. A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or\n5. Presence of documented splenomegaly (clinically assessed by palpation) or\n6. Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment)\n\n 1. Tiredness\n 2. Difficulty sleeping\n 3. Itching\n 4. Muscle aches and/or bone pain\n 5. Night sweats\n 6. Sweats while awake\n 7. Other"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Green Valley', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 31.85425, 'lon': -110.9937}}, {'city': 'Safford', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.83395, 'lon': -109.70758}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 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