MedPath

Anemia in the Elderly

Completed
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
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
Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

© Copyright 2025. All Rights Reserved by MedPath