NIH Clinical Research Studies

Protocol Number: 07-CC-0090

Active Accrual, Protocols Recruiting New Patients

Title:
Molecular Changes and Biomarkers in Chronic Myeloproliferative Disorders
Number:
07-CC-0090
Summary:
This study will evaluate white blood cells and plasma protein levels in people with myeloproliferative disorders to determine why some people's bone marrow makes too many blood cells and to develop a blood test that can be used to identify these patients. Myeloproliferative disorders include polycythemia vera (too many red blood cells), essential thrombocytosis (too many platelets, or thrombocytes) and idiopathic myelofibrosis (scar tissue of the bone marrow due to overproduction of cells).

People 18 years of age and older with a myeloproliferative disorder may be eligible for this study.

Participants have a physical examination, medical history and blood draw to collect 2 to 3 ounces (5 tablespoons) of blood for testing.

Sponsoring Institute:
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

1. 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.

2. Both male and female subjects will be studied.

3. Any ethnic group.

4. 18 years of age or older.

EXCLUSION CRITERIA:

Subjects will be excluded if they have any of the following conditions:

1. Increased blood counts due to a disease other than chronic myeloproliferation.

2. Know history of anemia (hematocrit less than 12.0 mg/dL).

3. Pregnancy.

4. Infection with HIV, hepatitis B, or hepatitis C.

Special Instructions:
Currently Not Provided
Keywords:
Polycythemia Vera
Essential Thrombocytosis
Idiopathic Myelofibrosis
Janus Kinase 2
CD177
Recruitment Keyword(s):
Chronic Myeloproliferative Disorders
Polycythemia Vera
PV
Essential Thrombocythemia
ET
Idiopathic Myelofibrosis
IM
Condition(s):
Polycythemia Vera
Essential Thrombocytosis
Idiopathic Myelofibrosis
Neutrophils
Chronic Myeloproliferative Disorders
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
Warren G. Magnuson Clinical Center

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
DAMESHEK W. Some speculations on the myeloproliferative syndromes. Blood. 1951 Apr;6(4):372-5.

Spivak JL. Polycythemia vera: myths, mechanisms, and management. Blood. 2002 Dec 15;100(13):4272-90. Epub 2002 Aug 8.

el-Kassar N, Hetet G, Briere J, Grandchamp B. Clonality analysis of hematopoiesis in essential thrombocythemia: advantages of studying T lymphocytes and platelets. Blood. 1997 Jan 1;89(1):128-34.

Active Accrual, Protocols Recruiting New Patients

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