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Status:

COMPLETED

Anemia in the Elderly

Lead Sponsor:

Stanford University

Conditions:

Anemia

Eligibility:

All Genders

20+ years

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 asp...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2009

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2011

    Estimated Enrollment :

    343 Patients enrolled

    Trial Details

    Trial ID

    NCT00640172

    Start Date

    August 1 2009

    End Date

    December 1 2011

    Last Update

    March 24 2016

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    VA Palo Alto Health Care System

    Palo Alto, California, United States, 94304

    2

    Stanford University School of Medicine

    Stanford, California, United States, 94305

    3

    University of Utah

    Salt Lake City, Utah, United States, 84132

    Anemia in the Elderly | DecenTrialz