Natural History Study for BEN
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|ClinicalTrials.gov Identifier: NCT00059423|
Recruitment Status : Completed
First Posted : April 25, 2003
Last Update Posted : July 1, 2020
In recent decades, hematologists have noticed that persons of African descent sometimes have lower white blood cell counts of a certain type, called granulocytes. These cells help to fight infections. The lower number of granulocytes in this situation does not appear to lead to more infections, and these individuals do not have any symptoms. This condition is called benign ethnic neutropenia (BEN), and is observed in a small percentage of individuals of African descent. This study will investigate the condition by studying people with and without BEN.
The goals of this study are to:
- identify individuals of African descent with BEN.
- determine the effects of two drugs, G-CSF and dexamethasone, on granulocyte production and movement.
- determine whether there are differences in those with and without BEN in the way genes are stimulated after the administration of G-CSF and dexamethasone.
Study participants will be asked to interview with the research team, undergo physical exams, donate a blood sample, and receive G-CSF by injection, followed by dexamethasone (orally) about three weeks later. They also will be required to undergo apheresis three times, a procedure in which blood is drawn from a donor and separated into its components. Some components are retained for research analyses, such as granulocytes, and small amount of blood; the remainder is returned by transfusion to the donor. This procedure will be required of participants before they receive G-CSF, the day after they receive G-CSF, and the day after they receive dexamethasone. Gene messages (mRNA will be isolated from granulocytes, and analyzed to better understand granulocyte growth and movement.
|Condition or disease|
|Neutropenia Agranulocytosis Hematologic Diseases Leukocyte Disorders Leukopenia|
|Study Type :||Observational|
|Actual Enrollment :||178 participants|
|Official Title:||Natural History and Molecular Characterization of Benign Ethnic Neutropenia in Individuals of African Descent|
|Actual Study Start Date :||June 3, 2003|
|Actual Primary Completion Date :||April 23, 2019|
|Actual Study Completion Date :||June 26, 2020|
Individuals of African descent with benign ethnic neutropenia (BEN) at baseline
Individuals of African descent without benign ethnic neutropenia (BEN) at baseline
- Serial blood counts in BEN [ Time Frame: Ongoing ]In our study, we hope to further elucidate the etiology of BEN in research subjects by isolating granulocyte mRNA after G-CSF and dexamethasone stimulation, applying microarray analyses to screen for gene expression differences, and confirming expression pattern differences by DNA analyses. We will focus on genes that are important in the proliferation and trafficking of neutrophils,such as PRV-1, elastase, myeloblastin, transcription factor PU.1, CAAT enhancing binding protein-alpha (C /EBP), stromal derived factor-1 (SDF-1), and CXC receptor-4 (CXCR4).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059423
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Matthew M Hsieh, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|