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- Klinische proef NCT00640172
Anemia in the Elderly
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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California
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Palo Alto, California, Verenigde Staten, 94304
- VA Palo Alto Health Care System
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Stanford, California, Verenigde Staten, 94305
- Stanford University School of Medicine
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- University of Utah
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Anemic Elderly
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Non-anemic adults (non-elderly, without bone marrow biopsy)
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Non-anemic adults (non-elderly, with bone marrow biopsy)
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Non-anemic Elderly (control without bone marrow biopsy)
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Non-anemic Elderly (control, with bone marrow biopsy)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Stanley L Schrier, MD, Stanford University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-05112
- SPO 36101 (Andere identificatie: Stanford University)
- SU-01082008-967 (Andere identificatie: Stanford University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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