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| Sponsor: | National Institutes of Health Clinical Center (CC) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00433862 |
Purpose
The three main chronic myeloproliferative disorders are polycythemia vera (PV), essential thrombocythemia (ET) and idiopathic myelofibrosis (IMF). These are clonal neoplastic diseases characterized by proliferation of one or more hematopoietic lineages. Recently a mutation of the Janus Kinase 2 (JAK2) gene that leads to the substitution of phenylalanine for valine at position 617 of the JAK2 protein, JAK2 V617F, has been found in 76% to 97% of patients with PV, 29% to 57% of patients with ET and 50% of patients with IMF. This mutation confers constitutive activity on to the JAK2 protein and appears to play an important role in the pathobiology of these conditions. However, not all patients with myeloproliferative disorders have this mutation and it may not be the primary cause of these diseases. The primary goal of this prospective natural history study is to investigate the molecular basis of these diseases in groups of patients who have JAK2 V617F and in those who do not. A second goal is to identify biomarkers for PV and the other myeloproliferative disorders that are easier to measure than JAK2 V617F. Approximately, 150 patients with myeloproliferative disorders will be studied over 3 years. The studies will involve the collection of 40 mL to 50 mL of peripheral blood from each subject. The blood will be used to assess neutrophil gene and protein expression, gene polymorphisms, and plasma protein levels.
| Condition |
|---|
|
Polycythemia Vera Essential Thrombocytosis Idiopathic Myelofibrosis Neutrophils Chronic Myeloproliferative Disorders |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders |
| Enrollment: | 8 |
| Study Start Date: | February 2007 |
The three main chronic myeloproliferative disorders are polycythemia vera (PV), essential thrombocythemia (ET) and idiopathic myelofibrosis (IMF). These are clonal neoplastic diseases characterized by proliferation of one or more hematopoietic lineages. Recently a mutation of the Janus Kinase 2 (JAK2) gene that leads to the substitution of phenylalanine for valine at position 617 of the JAK2 protein, JAK2 V617F, has been found in 76% to 97% of patients with PV, 29% to 57% of patients with ET and 50% of patients with IMF. This mutation confers constitutive activity on to the JAK2 protein and appears to play an important role in the pathobiology of these conditions. However, not all patients with myeloproliferative disorders have this mutation and it may not be the primary cause of these diseases. The primary goal of this prospective natural history study is to investigate the molecular basis of these diseases in groups of patients who have JAK2 V617F and in those who do not. A second goal is to identify biomarkers for PV and the other myeloproliferative disorders that are easier to measure than JAK2 V617F. Approximately, 150 patients with myeloproliferative disorders will be studied over 3 years. The studies will involve the collection of 40 mL to 50 mL of peripheral blood from each subject. The blood will be used to assess neutrophil gene and protein expression, gene polymorphisms, and plasma protein levels.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Subjects will be excluded if they have any of the following conditions:
Contacts and Locations| United States, District of Columbia | |
| VA Medical Center, Washington D.C. | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 070090, 07-CC-0090 |
| Study First Received: | February 9, 2007 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00433862 History of Changes |
| Health Authority: | United States: Federal Government |
|
Polycythemia Vera Essential Thrombocytosis Idiopathic Myelofibrosis Janus Kinase 2 CD177 Chronic Myeloproliferative Disorders |
Polycythemia Vera PV Essential Thrombocythemia ET Idiopathic Myelofibrosis IM |
|
Polycythemia Polycythemia Vera Myelofibrosis Disease Hematologic Diseases Blood Platelet Disorders Blood Coagulation Disorders Myeloproliferative Disorders |
Myeloid Metaplasia Lymphatic Diseases Hemorrhagic Disorders Pathologic Processes Thrombocytosis Thrombocythemia, Hemorrhagic Bone Marrow Diseases Splenic Diseases |