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NCT00433862 · ClinicalTrials.gov registry record
Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders
A clinical trial of Polycythemia Vera and Chronic Myeloproliferative Disorders, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 8
- Enrollment target
- 2
- Study locations
NCT00433862 is a study of Polycythemia Vera and Chronic Myeloproliferative Disorders that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 8 participants, below the 340-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00433862, a study of Polycythemia Vera and Chronic Myeloproliferative Disorders, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Study Locations (2)
District of Columbia
- VA Medical Center, Washington D.C. - Washington D.C.
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-02-06 |
| Est. Completion | 2010-05-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00433862
The ClinicalTrials.gov registry entry for NCT00433862 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 340-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (98% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Polycythemia Vera appearing as the primary indexed condition, and to 0 interventions.
NCT00433862 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00433862 about?
NCT00433862 is a clinical study titled "Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders". 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 (JAK...
What is the current status of trial NCT00433862?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2007-02-06. Estimated completion is 2010-05-19.
What conditions does trial NCT00433862 study?
This clinical trial studies the following conditions: Polycythemia Vera, Chronic Myeloproliferative Disorders, Essential Thrombocytosis, Idiopathic Myelofibrosis, Neutrophils.
Who is sponsoring clinical trial NCT00433862?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00433862 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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