CI

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ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00059423
NCT00059423N/ACompleted

Natural History and Molecular Characterization of Benign Ethnic Neutropenia in Individuals of African Descent

National Heart, Lung, and Blood Institute (NHLBI)·observational·Posted Apr 25, 2003·Updated Mar 22, 2024

In Brief

An observational study for Neutropenia and 4 related conditions. Completed, enrolled 178 participants across 1 site.

Detailed Summary

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: 1. identify individuals of African descent with BEN. 2. determine the effects of two drugs, G-CSF and dexamethasone, on granulocyte production and movement. 3. 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2003
Enrollment StartJun 3, 2003
Primary CompletionApr 23, 2019
Study CompletionJun 26, 2020
TodayJul 2, 2026
Enrollment to primary: 15.9 yearsPosted 23.2 years ago