| City: |
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Stanford |
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State:
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CA |
| Zip Code: |
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94305 |
| Conditions: |
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Anemia |
| Purpose: |
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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.
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| Study summary: |
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Potential study subjects will be referred by their primary providers (primary care
physicians, nurse practitioners) for the study or will respond to flyers placed in
outpatient clinics and the hospital setting. If potential anemic subjects or non-anemic
controls contact study personnel requesting to be in the study, their records if available
will be reviewed to determine eligibility. Alternatively, they may initially be seen in a
screening visit at which time a medical history will be obtained to determine patient
eligibility. A complete blood count (CBC, blood sample) may be drawn (if not already done
for clinical purposes) at this time to determine final eligibility. A research consent form
will be signed prior to this blood draw if blood is only being drawn for screening purposes
for the study.
If potential study subjects are eligible and agree to participate in the study, he or she
will come in for a baseline visit, at which time informed consent will be signed (if it has
not already been signed during the screening process), full data will be collected,
including demographics, contact information, medical history, medications, social history,
partial physical examination.
Generally, most anemic subjects will have a laboratory workup for their anemia done as part
of the clinical evaluation; if the following tests are not done in this capacity, they may
be done for the study: peripheral smear, iron studies, serum creatinine, serum
erythropoietin, reticulocyte count, vitamin B12 and folate levels.
In addition, all participants who consent to do so will have the following additional
research tests done: urine for urinary creatinine and urinary hepcidin (urinary hepcidin
tests will be run by the laboratory of Dr. Tomas Ganz at UCLA; in those who consent a
portion of the urine sample will be tissue banked for other analyses in the future. Samples
from VA patients will be stored for 10 years and then destroyed); and blood drawn for serum
soluble transferrin receptor, C-reactive protein, erythrocyte sedimentation rate, D-Dimer,
and blood for 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 either at at the laboratory of Drs. Paul
Luciw and Imran Khan at University of California, Davis (UC, Davis) or as a sendout test to
Linco Diagnostics (www.lincodiagnostics.com). Cytokine levels may also be run clinically.
Neopterin, tryptophan and other levels may be run at the lab of Dr. Deitma Fuchs in Austria.
In addition, in all 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.
Samples from VA patients will be stored for 10 years and then destroyed. Blood tests for all
samples will be collected by venipuncture and stored in vacuum tubes. The total amount of
blood collected for research purposes will be a maximum of 90 cc.
In the event that there is a lab error in collecting, labeling or storing the first
additional blood and urine sample, and if the patient consents, a second additional blood
and urine sample will be collected and the participant will be paid an additional $40.
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, and if this is not a clinically indicated procedure, they will be offered $300
compensation for undergoing the procedure. 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), however these subjects will not be offered any compensation.
Aspirate and biopsy procedures will have an additional clinical consent form. In those who
consent, a portion of the bone marrow specimens may be tissue banked for other analyses in
the future. Samples from VA patients will be stored for 10 years and then destroyed. 6-30
elderly (65 and older) non-anemic controls and 6-30 young (20-35 years old) non anemic
controls will undergo bone marrow biopsy and aspirate to serve as controls. They will be
recruited via flyers placed around the community, and given $300 compensation for undergoing
the procedure. |
| Criteria: |
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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 |
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| Study is available at: |
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Stanford University School of Medicine
Stanford, CA 94305
United States
Primary Contact:
Renee Mehra, MS
Email: ramehra@stanford.edu
Phone: 650-736-1836
Secondary Contact:
Renee Mehra, MS
Email: ramehra@stanford.edu
Phone: (650) 736-1836 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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