Status:
COMPLETED
Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Polycythemia Vera
Essential Thrombocytosis
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis or suspected diagnosis of PV, ET, or IMF. The World Health Organization Criteria will be used for diagnosing this disorder. In brief, the criteria for PV is hemoglobin greater than 18.5 g/dL in men and greater than 16.5 g/dL in women and splenomegaly on palpation in the absence of secondary erythrocytosis. If splenomegaly is absent, the patient must have 2 of the following 4 minor criteria: platelet count greater than 400 x 10(9)/L, leukocyte count greater than 12 x 10(9)/L, marrow biopsy with trilineage increase in cellularity, and low serum erythropoietin level. The criteria for EF is a platelet count greater than 600 x 10(9)/L with no known cause of reactive thrombocytosis and a normal hemoglobin. The criteria for IMF is fibrosis of the bone marrow and splenomegaly without preceding PV, ET or chronic myelogenous leukemia.
- Both male and female subjects will be studied.
- Any ethnic group.
- 18 years of age or older.
- EXCLUSION CRITERIA:
- Subjects will be excluded if they have any of the following conditions:
- Increased blood counts due to a disease other than chronic myeloproliferation.
- Know history of anemia (hematocrit less than 12.0 mg/dL).
- Pregnancy.
- Infection with HIV, hepatitis B, or hepatitis C.
Exclusion
Key Trial Info
Start Date :
February 6 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00433862
Start Date
February 6 2007
End Date
May 19 2010
Last Update
July 2 2017
Active Locations (2)
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1
VA Medical Center, Washington D.C.
Washington D.C., District of Columbia, United States, 20422
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892