Anemia in the Elderly
- Conditions
- Anemia
- Registration Number
- NCT00640172
- Lead Sponsor
- Stanford University
- Brief Summary
Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus additional laboratory tests to determine the etiology of the anemia. In a subset of subjects, bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young controls (purchased).
- Detailed Description
Eligible elderly men and women with anemia will undergo a full hematologic evaluation (blood sample for complete blood count, CBC) to determine the etiology of the anemia (eg, myelodysplastic syndrome). Peripheral smears; iron studies; serum creatinine; serum erythropoietin; reticulocyte count; vitamin B12; and folate levels may be obtained/conducted. When no etiology is identified (ie, "unexplained anemia"), additional laboratory tests will be performed which will include some or all of urinary hepcidin levels; plasma cytokine levels; serum soluble transferrin receptor; C-reactive protein; erythrocyte sedimentation rate; D-Dimer; neopterin level; tryptophan level; and blood for a cytokine profile that may include IL-1, IL-6, TNF-alpha, and VEGF levels. Serum; plasma; and nucleated peripheral blood cells may be banked for future DNA and other analyses. In a subset of those found to have either unexplained anemia (approximately 6 to 30 subjects) or anemia of chronic inflammation (approximately 6 to 30 subjects) , bone marrow aspirate and biopsies may be performed for a planned analysis of erythroid progenitor and stem cells in these populations. In addition, plasma and serum and bone marrow samples will be obtained from elderly non-anemic controls (approximately 6 to 30 subjects), and bone marrow samples will be purchased for non-anemic young controls (approximately 6 to 30 subjects) .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 343
Non-anemic adult control (non-elderly), for blood and urine samples only
- Age 20 to 64
- Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women) within at least 90 days of enrollment into the study
- Normal white blood cell and platelet counts
- Independent / community living
- Written informed consent obtained
- Performance level ECOG 2 or better
- Will be recruited by the following age strata: 20 to < 35; 35 to < 50; 50 to < 65.
INCLUSION CRITERIA: Non-anemic adult control (non-elderly), with bone marrow biopsy
- Age 20 to 35
- Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women)
EXCLUSION CRITERIA: For all groups
-
Substance abuse or mental health or other problems that would make compliance with the protocol unlikely
-
Predicted mortality in less than 3 months, based on co-morbidities
-
Known diagnosis of bone marrow disorder such as
- Leukemia
- Metastatic malignancy with bone marrow involvement
- Myelodysplastic syndrome
- Monoclonal gammopathy of undetermined significance (MGUS)
-
On any erythropoiesis-stimulating agent in the prior 3 months
-
Having received any red blood cell transfusion in the prior 3 months
-
End stage renal disease as defined by the need for ongoing hemo or peritoneal dialysis
-
Endstage liver disease as defined by the patient¡-s providers in the medical record
-
A medical condition which would make participation risky
-
On any other study requiring ongoing blood or marrow donation which would make additional blood or marrow collection risky to the subject
EXCLUSION CRITERIA: Additional, for healthy controls:
- History of active malignancy (except non-melanoma skin cancer), or radiation or chemotherapy for treatment of malignancy within the past 24 months
- HIV positivity
- Hepatitis B or Hepatitis C positivity
- Autoimmune disease (including lupus, RA, IBD)
- Known hematologic disorder
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States