Anemia in the Elderly

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) .

INCLUSION CRITERIA: Anemic elderly :

- Age 65 or older

- Hemoglobin < 13 g/dL (men) or < 12 g/dL (women) on at least 2 occasions 30 days
apart, with the most recent value within at least 14 days of enrollment into the
study. In addition, if a CBC is drawn on the date of enrollment, hemoglobin must meet
eligibility criteria in order for the patient to enroll.

- Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto
Health Care System

- Independent/community living

- Ability to understand and the willingness to sign a written informed consent document

- Performance level ECOG 2 or better.

INCLUSION CRITERIA: Non-anemic elderly control, for blood and urine samples, with or
without bone marrow biopsy

- Age 65 or older

- 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

- Ability to understand and the willingness to sign a written informed consent document

- Performance level ECOG 2 or better

- Matched to UA population by gender and 10-year age strata (65 to < 75; 75 to < 85; 85
or older).

INCLUSION CRITERIA: Non-anemic adult control (non-elderly), for blood and urine samples,
with bone marrow biopsy

- Age 20 to 35

- 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

Inclusion Criteria: 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