Anemia in the Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00640172
First received: March 6, 2008
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anemia in the Elderly

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA

blood, urine and bone marrow


Estimated Enrollment: 603
Study Start Date: March 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatient elderly men and women (aged 65 years or older) with anemia.

Criteria

Inclusion Criteria:ELDERLY ANEMIC:

  1. Age 65 or older
  2. Hemoglobin < 13 g/dL (in men) and < 12 g/dL (in 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.
  3. Outpatient at either the VAPAHCS or SHC
  4. Independent/community living
  5. Ability to understand and the willingness to sign a written informed consent document
  6. Performance level ECOG 2 or better.

NON-ANEMIC ELDERLY CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH OR WITHOUT BONE MARROW BIOPSY:

  1. Age 65 or older
  2. Hemoglobin ¡Ý 13.0 g/dL (in men) or ¡Ý 12.0 g/dL (in women) within at least 90 days of enrollment into the study
  3. Normal white blood cell and platelet counts
  4. Independent/ community living
  5. Ability to understand and the willingness to sign a written informed consent document
  6. Performance level ECOG 2 or better
  7. Matched to UA population by gender and 10 year age strata (65 to < 75, 75 to < 85, 85 or older).

NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH BONE MARROW BIOPSY:

  1. Age 20-35
  2. Hemoglobin ¡Ý 13.0 g/dL (in men) or ¡Ý 12.0 g/dL (in women) within at least 90 days of enrollment into the study
  3. Normal white blood cell and platelet counts
  4. Independent/ community living
  5. Written informed consent obtained
  6. Performance level ECOG 2 or better

NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES ONLY:

  1. Age 20-64
  2. Hemoglobin ¡Ý 13.0 g/dL (in men) or ¡Ý 12.0 g/dL (in women) within at least 90 days of enrollment into the study
  3. Normal white blood cell and platelet counts
  4. Independent/community living
  5. Written informed consent obtained
  6. Performance level ECOG 2 or better
  7. Will be recruited by the following age strata: 20 to < 35, 35 to < 50, 50 to < 65.

NON-ANEMIC YOUNG CONTROL POPULATION FOR BONE MARROW ONLY (these samples will be purchased from an outside vendor):

  1. Age 20-35
  2. Hemoglobin >= 13 g/dL in men, >= 12 g/dL in women as obtained by procurement company.

Exclusion Criteria:Exclusion criteria for all groups

  1. Substance abuse or mental health or other problems that would make compliance with the protocol unlikely
  2. Predicted mortality based on co-morbidities of less than 3 months
  3. Known diagnosis of bone marrow disorder such as leukemia, metastatic malignancy with bone marrow involvement, myelodysplastic syndrome. Monoclonal gammopathy of undetermined significance (MGUS) will be excluded as well due to difficulty in diagnosing MGUS in the presence of anemia which fulfills criteria for end-organ damage for multiple myeloma.
  4. On any erythropoiesis-stimulating agent in the prior 3 months
  5. Having received any red blood cell transfusion in the prior 3 months
  6. End stage renal disease as defined by the need for ongoing hemo or peritoneal dialysis
  7. Endstage liver disease as defined by the patient¡-s providers in the medical record
  8. A medical condition which would make participation risky
  9. On any other study requiring ongoing blood or marrow donation which would make additional blood or marrow collection risky to the subject

Additional exclusion criteria for healthy controls:

  1. History of active malignancy (except non-melanoma skin cancer), or radiation or chemotherapy for treatment of malignancy within the past 24 months
  2. HIV positivity
  3. Hepatitis B or Hepatitis C positivity
  4. Autoimmune disease (including lupus, RA, IBD)
  5. Known hematologic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640172

Contacts
Contact: Renee Mehra, MS (650) 736-1836 ramehra@stanford.edu

Locations
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, MS    650-736-1836    ramehra@stanford.edu   
Contact: Elizabeth A Price, M.D.    (650) 736-7767    eaprice@stanford.edu   
Sub-Investigator: Linda M Boxer         
Sub-Investigator: Elizabeth Price         
Principal Investigator: Stanley L Schrier         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kimberly Hickman    801-581-3707    Kimberly.Hickman@hsc.utah.edu   
Sub-Investigator: Neeraj Agarwal         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley L Schrier Stanford University
  More Information

No publications provided

Responsible Party: Stanley L Schrier, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00640172     History of Changes
Other Study ID Numbers: SU-01082008-967, SPO # 36101, eProtocol ID: 5112
Study First Received: March 6, 2008
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014