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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00640172 |
485 outpatient elderly men and women with anemia will be enrolled, and each participant will undergo a full hematologic evaluation in order to determine the etiology of the anemia. In those in whom no etiology is found (those with "unexplained anemia"), additional laboratory tests will be performed including urinary hepcidin and plasma cytokine levels. In a subset of those found to have either unexplained anemia or anemia of chronic inflammation, bone marrow aspirate and biopsies will be performed for a planned analysis of erythroid progenitor and stem cells in these populations. In addition, we will obtain plasma and serum and bone marrow samples in elderly non anemic controls, and bone marrow samples will be purchased in non anemic young controls.
Condition |
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Anemia |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Anemia in the Elderly |
blood, urine and bone marrow samples may be stored for future use in those who consent
Estimated Enrollment: | 603 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Eligible patients will be recruited from either Stanford Hospital and Clinics (SHC) or the Veterans Affairs Palo Alto Health Care System (VAPAHCS).
Evaluation for anemia will include a complete blood count, reticulocyte count, careful review of the peripheral smear, evaluation for nutrient deficiencies (iron, B12 and folate), and renal and thyroid dysfunction, with additional evaluation dependent on initial findings. Patients will be categorized according to the etiology of the anemia.
In addition, all subjects who consent to do so will have the following additional research tests done: 40 mL of urine for urinary creatinine and urinary hepcidin; and 35 cc of blood drawn for serum soluble transferrin receptor (if not already done), C-reactive protein, erythrocyte sedimentation rate, D-Dimer, and a cytokine profile including IL-6 level by ELISA and/or IL-1, IL-6, TNF-alpha, VEGF levels which will be run by multiplex assay or other immunologic methods, and neopterin, tryptophan and other levels.
In addition, in those who consent, 50 cc will be drawn for tissue banking serum, plasma and nucleated peripheral blood cells for possible DNA and other analyses in the future.
A subset of subjects (approximately 6-30 subjects with anemia of chronic inflammation, and 6-30 subjects with unexplained anemia) will have bone marrow aspiration and biopsy specimens obtained. Aspirate and biopsy specimens will also be obtained if clinically indicated to determine the etiology of the anemia (i.e. to evaluate for myelodysplastic syndrome).
59 elderly (>= 65 years of age) non-anemic participants will be enrolled as elderly healthy controls for phlebotomy and urinalysis; 6-30 of these will be recruited for a bone marrow aspirate and biopsy. They will be recruited via flyers placed in outpatient clinics, the hospital setting, and in the community.
59 young (20-64 years of age) non-anemic participants will be enrolled as young healthy controls (without bone marrow studies) for phlebotomy and urinalysis; 6-30 of these (aged 20-35 years) will be recruited for a bone marrow aspirate and biopsy. Non-anemic controls with bone marrow biopsy and aspirate will be recruited via flyers placed in outpatient clinics, the hospital setting, and in the community. In addition. 6-10 bone marrow samples from young healthy controls will be purchased from an outside vendor.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Outpatient from Stanford and VA hospitals
Inclusion Criteria:ELDERLY ANEMIC:
NON-ANEMIC ELDERLY CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH OR WITHOUT BONE MARROW BIOPSY:
NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH BONE MARROW BIOPSY:
NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES ONLY:
NON-ANEMIC YOUNG CONTROL POPULATION FOR BONE MARROW ONLY (these samples will be purchased from an outside vendor):
Exclusion Criteria:Exclusion criteria for all groups
Additional exclusion criteria for healthy controls:
Contact: Renee Mehra, PG Dip Epidemiology | (650) 736-1836 | ramehra@stanford.edu |
United States, California | |
VA Palo Alto Health Care System | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Renee Mehra, PG Dip Epidemiology (650) 736-1836 ramehra@stanford.edu | |
Principal Investigator: Lawrence Leung | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Renee Mehra, PG Dip Epidemiology (650) 736-1836 ramehra@stanford.edu | |
Contact: Elizabeth A Price, M.D. (650) 736-7767 eaprice@stanford.edu | |
Principal Investigator: Stanley L Schrier | |
Sub-Investigator: Elizabeth Price | |
Sub-Investigator: Linda M Boxer |
Principal Investigator: | Stanley L Schrier | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Stanley L Schrier, Principal Investigator ) |
Study ID Numbers: | SU-01082008-967, SPO # 36101, eProtocol ID: 5112 |
Study First Received: | March 6, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00640172 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hematologic Diseases Anemia |
Hematologic Diseases Anemia |