AnemiaNCT00640172
Anemia in the Elderly
An observational study of Anemia, run by Stanford University at 3 sites in United States.
Trial summary
Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus additional laboratory tests to determine the etiology of the anemia. In a subset of subjects, bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid progenitor and stem cells. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 343 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient elderly men and women (aged 65 years or older) with anemia, and corresponding elderly controls and adult non-elderly controls.
Who may be able to join
- 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.
Show all 32Show fewer
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Palo Alto Health Care System
Palo Alto, California, 94304
University of Utah
Salt Lake City, Utah, 84132
Stanford University School of Medicine
Stanford, California, 94305
About this study
Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus additional laboratory tests to determine the etiology of the anemia. In a subset of subjects, bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young controls (purchased).
Read the detailed description
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) .
- Conditions
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anemic Elderly | Not described | |
| Non-anemic adults (non-elderly, without bone marrow biopsy) | Not described | |
| Non-anemic adults (non-elderly, with bone marrow biopsy) | Not described | |
| Non-anemic Elderly (control without bone marrow biopsy) | Not described | |
| Non-anemic Elderly (control, with bone marrow biopsy) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley L Schrier, Stanford University
- Investigators
- Stanley L Schrier, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640172
- Sponsor's protocol ID
- IRB-05112
- Other IDs
- SPO 36101, SU-01082008-967
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2008
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Price EA, Mehra R, Holmes TH, Schrier SL. Anemia in older persons: etiology and evaluation. Blood Cells Mol Dis. 2011 Feb 15;46(2):159-65. doi: 10.1016/j.bcmd.2010.11.004. Epub 2011 Jan 3.
PubMed 21208814
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia in the Elderly
- ClinicalTrials.gov ID
- NCT00640172
- Acronym / sponsor ID
- IRB-05112
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible elderly men and women with anemia will undergo a full hematologic evaluation plus additional laboratory tests to determine the etiology of the anemia. In a subset of subjects, bone marrow aspirate and biopsies will be obtained for a planned analysis of erythroid progenitor and stem cells. Plasma; serum; and bone marrow samples will be will be compared to elderly non-anemic controls. Bone marrow samples will also be compared to non-anemic young controls (purchased).
Detailed description
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) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient elderly men and women (aged 65 years or older) with anemia, and corresponding elderly controls and adult non-elderly controls.
Key inclusion criteria (32 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- On any erythropoiesis-stimulating agent in the prior 3 months
- Having received any red blood cell transfusion in the prior 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Results publication: PubMed 21208814Price EA, Mehra R, Holmes TH, Schrier SL. Anemia in older persons: etiology and evaluation. Blood Cells Mol Dis. 2011 Feb 15;46(2):159-65. doi: 10.1016/j.bcmd.2010.11.004. Epub 2011 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Sickle Cell Disease, Sickle Cell Anaemia
RecruitingPhase 2
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
Severe Aplastic Anemia (SAA), Hypo-Plastic Myelodysplastic Syndrome (MDS)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley L Schrier, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.