Stanley Schrier
Anemia in the Elderly
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
Phase:
N/AEligibility
Ages Eligible for Study:
20 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key 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 ?? 13.0 g/dL (in men) or ?? 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 ?? 13.0 g/dL (in men) or ?? 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 ?? 13.0 g/dL (in men) or ?? 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.
Key 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
Additional Study Details
Official Title:
Anemia in the ElderlyAnticipated start date:
3/1/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
Cross-sectionalSelection:
Defined PopulationTiming:
ProspectiveTotal Number to be Enrolled:
603Total Number to be Enrolled at Stanford:
302More Information
Secondary ID(s):
- SPO # 36101
- eProtocol ID: 5112
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
11/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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