Anemia in the Elderly
Recruitment status was Recruiting
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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 |
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 |
Outpatient elderly men and women (aged 65 years or older) with anemia.
Inclusion Criteria:ELDERLY ANEMIC:
- Age 65 or older
- 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.
- Outpatient at either the VAPAHCS or SHC
- Independent/community living
- Ability to understand and the willingness to sign a written informed consent document
- Performance level ECOG 2 or better.
NON-ANEMIC ELDERLY CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH OR WITHOUT BONE MARROW BIOPSY:
- Age 65 or older
- 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
- 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).
NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES WITH BONE MARROW BIOPSY:
- Age 20-35
- 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
- Normal white blood cell and platelet counts
- Independent/ community living
- Written informed consent obtained
- Performance level ECOG 2 or better
NON-ANEMIC YOUNG CONTROL POPULATION FOR BLOOD AND URINE SAMPLES ONLY:
- Age 20-64
- 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
- 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.
NON-ANEMIC YOUNG CONTROL POPULATION FOR BONE MARROW ONLY (these samples will be purchased from an outside vendor):
- Age 20-35
- Hemoglobin >= 13 g/dL in men, >= 12 g/dL in women as obtained by procurement company.
Exclusion Criteria:Exclusion criteria for all groups
- Substance abuse or mental health or other problems that would make compliance with the protocol unlikely
- Predicted mortality based on co-morbidities of less than 3 months
- 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.
- 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
Additional exclusion criteria 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
Contacts and Locations| Contact: Renee Mehra, MS | (650) 736-1836 | ramehra@stanford.edu |
| 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 | |
| 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 June 17, 2013