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Anemia in the Elderly
This study is currently recruiting participants.
Verified by Stanford University, April 2009
First Received: March 6, 2008   Last Updated: April 30, 2009   History of Changes
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00640172
  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: 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

Biospecimen Description:

blood, urine and bone marrow samples may be stored for future use in those who consent


Estimated Enrollment: 603
Study Start Date: April 2006
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Eligible patients will be recruited from either Stanford Hospital and Clinics (SHC) or the Veterans Affairs Palo Alto Health Care System (VAPAHCS).

Evaluation for anemia will include a complete blood count, reticulocyte count, careful review of the peripheral smear, evaluation for nutrient deficiencies (iron, B12 and folate), and renal and thyroid dysfunction, with additional evaluation dependent on initial findings. Patients will be categorized according to the etiology of the anemia.

In addition, all subjects who consent to do so will have the following additional research tests done: 40 mL of urine for urinary creatinine and urinary hepcidin; and 35 cc of blood drawn for serum soluble transferrin receptor (if not already done), C-reactive protein, erythrocyte sedimentation rate, D-Dimer, and a cytokine profile including IL-6 level by ELISA and/or IL-1, IL-6, TNF-alpha, VEGF levels which will be run by multiplex assay or other immunologic methods, and neopterin, tryptophan and other levels.

In addition, in those who consent, 50 cc will be drawn for tissue banking serum, plasma and nucleated peripheral blood cells for possible DNA and other analyses in the future.

A subset of subjects (approximately 6-30 subjects with anemia of chronic inflammation, and 6-30 subjects with unexplained anemia) will have bone marrow aspiration and biopsy specimens obtained. Aspirate and biopsy specimens will also be obtained if clinically indicated to determine the etiology of the anemia (i.e. to evaluate for myelodysplastic syndrome).

59 elderly (>= 65 years of age) non-anemic participants will be enrolled as elderly healthy controls for phlebotomy and urinalysis; 6-30 of these will be recruited for a bone marrow aspirate and biopsy. They will be recruited via flyers placed in outpatient clinics, the hospital setting, and in the community.

59 young (20-64 years of age) non-anemic participants will be enrolled as young healthy controls (without bone marrow studies) for phlebotomy and urinalysis; 6-30 of these (aged 20-35 years) will be recruited for a bone marrow aspirate and biopsy. Non-anemic controls with bone marrow biopsy and aspirate will be recruited via flyers placed in outpatient clinics, the hospital setting, and in the community. In addition. 6-10 bone marrow samples from young healthy controls will be purchased from an outside vendor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatient from Stanford and VA hospitals

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 >= 13 (in men) or >= 12 (in women) within 30 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 >= 13 g/dL (in men) or >= 12 g/dL (in women) within at least 30 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 >= 13 g/dL (in men) or >= 12 g/dL (in women) within 30 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640172

Contacts
Contact: Renee Mehra, PG Dip Epidemiology (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, PG Dip Epidemiology     (650) 736-1836     ramehra@stanford.edu    
Contact: Elizabeth A Price, M.D.     (650) 736-7767     eaprice@stanford.edu    
Principal Investigator: Stanley L Schrier            
Sub-Investigator: Elizabeth Price            
Sub-Investigator: Linda M Boxer            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley L Schrier Stanford University
  More Information

No publications provided

Responsible Party: Stanford University School of Medicine ( Stanley L Schrier, Principal Investigator )
Study ID Numbers: SU-01082008-967, SPO # 36101, eProtocol ID: 5112
Study First Received: March 6, 2008
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00640172     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Hematologic Diseases
Anemia

Additional relevant MeSH terms:
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on September 10, 2009