Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433862
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-02-09
Brief Title:
Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2010-05-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-CC-0090 | None | None | None |