Anemia in the Elderly
Palabras clave
Abstracto
Descripción
Eligible elderly men and women with anemia will undergo a full hematologic evaluation (blood sample for complete blood count, CBC) to determine the etiology of the anemia (eg, myelodysplastic syndrome). Peripheral smears; iron studies; serum creatinine; serum erythropoietin; reticulocyte count; vitamin B12; and folate levels may be obtained/conducted. When no etiology is identified (ie, "unexplained anemia"), additional laboratory tests will be performed which will include some or all of urinary hepcidin levels; plasma cytokine levels; serum soluble transferrin receptor; C-reactive protein; erythrocyte sedimentation rate; D-Dimer; neopterin level; tryptophan level; and blood for a cytokine profile that may include IL-1, IL-6, TNF-alpha, and VEGF levels. Serum; plasma; and nucleated peripheral blood cells may be banked for future DNA and other analyses. In a subset of those found to have either unexplained anemia (approximately 6 to 30 subjects) or anemia of chronic inflammation (approximately 6 to 30 subjects) , bone marrow aspirate and biopsies may be performed for a planned analysis of erythroid progenitor and stem cells in these populations. In addition, plasma and serum and bone marrow samples will be obtained from elderly non-anemic controls (approximately 6 to 30 subjects), and bone marrow samples will be purchased for non-anemic young controls (approximately 6 to 30 subjects) .
fechas
| Verificado por última vez: | 02/29/2016 |
| Primero enviado: | 03/05/2008 |
| Inscripción estimada enviada: | 03/13/2008 |
| Publicado por primera vez: | 03/20/2008 |
| Última actualización enviada: | 03/22/2016 |
| Última actualización publicada: | 03/23/2016 |
| Fecha de inicio real del estudio: | 07/31/2009 |
| Fecha estimada de finalización primaria: | 11/30/2011 |
| Fecha estimada de finalización del estudio: | 11/30/2011 |
Condición o enfermedad
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Anemic Elderly | |
| Non-anemic adults (non-elderly, without bone marrow biopsy) | |
| Non-anemic adults (non-elderly, with bone marrow biopsy) | |
| Non-anemic Elderly (control without bone marrow biopsy) | |
| Non-anemic Elderly (control, with bone marrow biopsy) |
Criterio de elegibilidad
| Edades elegibles para estudiar | 20 Years A 20 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | INCLUSION CRITERIA: Anemic elderly : - Age 65 or older - Hemoglobin < 13 g/dL (men) or < 12 g/dL (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 Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System - Independent/community living - Ability to understand and the willingness to sign a written informed consent document - Performance level ECOG 2 or better. INCLUSION CRITERIA: Non-anemic elderly control, for blood and urine samples, with or without bone marrow biopsy - Age 65 or older - Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (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). INCLUSION CRITERIA: Non-anemic adult control (non-elderly), for blood and urine samples, with bone marrow biopsy - Age 20 to 35 - Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (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 Inclusion Criteria: Non-anemic adult control (non-elderly), for blood and urine samples only - Age 20 to 64 - Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (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. INCLUSION CRITERIA: Non-anemic adult control (non-elderly), with bone marrow biopsy - Age 20 to 35 - Hemoglobin ≥ 13 g/dL (men) or ≥ 12 g/dL (women) EXCLUSION CRITERIA: For all groups - Substance abuse or mental health or other problems that would make compliance with the protocol unlikely - Predicted mortality in less than 3 months, based on co-morbidities - Known diagnosis of bone marrow disorder such as - Leukemia - Metastatic malignancy with bone marrow involvement - Myelodysplastic syndrome - Monoclonal gammopathy of undetermined significance (MGUS) - 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 EXCLUSION CRITERIA: Additional, 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 |
