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Home > "G" Clinical Trials Conditions > Gene Message (mRNA) Analysis of Granulocytes  Gene Message (mRNA) Analysis of Granulocytes
Gene Message (mRNA) Analysis of Granulocytes
For Condition: Neutropenia
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: Benign ethnic neutropenia (BEN) is defined by peripheral blood absolute neutrophil count less than 1.5 x 10(9) per liter without an increase in infections. This condition has been described in individuals of African descent. Although these individuals have normal myeloid maturation on bone marrow examinations, they appear to release fewer neutrophils into the circulation when stimulated by hydrocortisone, compared to normal controls. This suggests that there may be differences in the regulation of neutrophil release or trafficking. In the past decade, granulocyte-colony stimulating factor (G-CSF) has been widely used in a variety of clinical settings, from patients with chemotherapy-induced neutropenia to normal volunteers for peripheral blood stem cell collection. G-CSF, however, has not been used in individuals with BEN. Furthermore, gene expression in neutrophil proliferation and trafficking has not been studied in these individuals. The purpose of this study is four-fold: first to identify individuals with BEN; second to characterize and compare neutrophil response to dexamethasone and G-CSF; third to compare the pattern of neutrophil gene expression by microarray analyses; and fourth to determine if mutations are present at the DNA level to account for gene expression pattern differences, in individuals of African descent with and without BEN at baseline, post dexamethasone, and post G-CSF stimulation.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Individuals of African descent of age 18 or greater Normal renal function: creatinine less than 1.5 mg/dl and proteinuria less than 1+ Normal liver function: bilirubin less than 1.5 mg/dl and transaminases within normal limits For control subjects: WBC within normal range (3,300 -9,600/mm(3)), granulocytes greater than or equal to 1,500/mm(3), platelets greater than 150,000/mm(3), hemoglobin greater than 12.5 g/dL, and normal MCV For benign ethnic neutropenic subjects: two blood counts, at least 1 month apart, in the last 6 months, with granulocytes less than 1,500/mm(3), platelet greater than 150,000/mm(3), hemoglobin greater than 12.5 g/dL, and normal MCV Female volunteers of childbearing age should not be pregnant Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research uses (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1) Ability to give informed consent to participate in the protocol EXCLUSION CRITERIA: Any underlying hematologic disorder including anemia, thalassemia, and sickle cell trait or disease Current use of corticosteroids, e.g. prednisone, dexamethasone, or hydrocortisone. Corticosteroids must be discontinued at least one month prior Active or chronic viral, bacterial, fungal, or parasitic infection. Any antibiotic use should be discontinued at least one month prior History of autoimmune disease, such as rheumatoid arthritis or systemic lupus erythematosus, or positive anti-nuclear antibody (ANA ELISA) of 3 E.U. (ELISA units) or greater Low B12 or folate levels, or abnormal thyroid function tests History of cancer or chemotherapy, except squamous carcinoma of the skin and cervical carcinoma in situ Pregnant woman or positive urine pregnancy test History of cardiovascular disease or related symptoms, such as chest pain or dyspnea Any positive serum screening test as listed below Allergy to G-CSF or bacterial E. coli products
Total Enrollment: 120
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030168; 03-DK-0168
Study Start Date: April 22, 2003
Record last reviewed: February 9, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059423
Other Neutropenia Studies:
1. Prophylaxis Trial of Posaconazole vs. Standard Azole Therapy for Neutropenic Patients
2. Gene Message (mRNA) Analysis of Granulocytes
3. Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
4. A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia
5. Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
Related Studies:
Other Neutropenia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Gene Message (mRNA) Analysis of Granulocytes
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