Aging, Geriatric Syndromes and Clonal Hematopoiesis Study

This observational study is looking at how aging and heart disease are connected to changes in blood stem cells, called clonal hematopoiesis. Researchers want to understand if these changes are linked to geriatric syndromes (common health problems in older adults) and cardiovascular diseases (heart and blood vessel conditions), independent of a person's age. You would participate in assessments like cognitive tests, questionnaires about daily activities, and a self-reported performance scale. The goal is to track these changes over 10 years to see if they predict the risk of developing blood cancer, geriatric syndromes, or heart disease. Adults aged 50 and older who can understand English are eligible to join.

Study design
This is an observational study planning to enroll 2000 participants. It is not a treatment study, but rather aims to understand how different factors are connected.
What's involved
You would complete cognitive assessments and questionnaires about your daily functional status at baseline and every 6 months until death. This includes questions about activities of daily living, instrumental activities of daily living, performance rating, and number of falls.
Compensation
Not stated in the trial record.
Follow-up
The study aims to measure outcomes over an estimated 10-year period.

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NCT02604563

Aging, Geriatric Syndromes and Clonal Hematopoiesis

Recruiting
Not specifiedAges 50+Observational
Washington University School of Medicine
~2,000 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Cognitive AssessmentActivities of Daily Living QuestionnaireInstrumental Activities of Daily Living, subscale of the OARSKarnofsky Self-reported Performance Rating ScaleNumber of FallsPhysical Health Section, subscale of the OARS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Background mutation rate in hematopoietic stem cells from older adults regardless of a prior cancer diagnosis as measured by the number and frequency of hematopoietic-specific mutations
Measured over Estimated to be 10 years
+4 more outcomes measured
Geriatrics
Aged
Geriatric Syndromes
Cardiovascular Diseases
1 sites across 1 states
Missouri1
  • Meagan Jacoby, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

At least 50 years of age.
Able to understand written and spoken English.
Able to understand and willing to sign an IRB-approved written informed consent document (or that of a legally authorized representative, if applicable for the trauma cohort)

Exclusion

Inability or unwillingness to complete health questionnaire (with the exception of hip and knee replacement participants).
History of a recent (\<30 days) acute viral illness.
Current cancer diagnosis and currently receiving chemotherapy or undergoing radiation therapy. A prior history of cancer is allowed if the participant completed therapy \> 1 year prior to enrollment; participants with a prior diagnosis of cancer will be asked to sign a release of information for the research team to obtain records regarding their prior cancer treatment.
Current use of drugs that cause DNA damage (e.g. Cytoxan, azathioprine, etc.) for the treatment of a non-malignant disease.
Vulnerable populations (e.g. prisoners).
Known infection with Hepatitis B or C, HTLV, or HIV.
Additional exclusion for optional bone marrow aspirate/biopsy substudy:
Use of medications for anticoagulation or "blood thinning" including warfarin, low molecular weight heparins (enoxaparin, daltaparin) or direct-acting oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban or betrixaban)
allergy to lidocaine or other local anesthetics.
  • Background mutation rate in hematopoietic stem cells from older adults regardless of a prior cancer diagnosis as measured by the number and frequency of hematopoietic-specific mutationsEstimated to be 10 years

    -The investigators will sequence the coding region of some or all of the genes in an individual's blood cells and compare results to their matched mouth cells to define hematopoietic-specific mutations. The number of hematopoietic-specific mutations per individual and the frequency of individuals with mutations will be measured.

  • Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutationsEstimated to be 10 years

    -The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals.

  • Determine the natural history of mutations in older adults with clonal hematopoiesis as measured by risk to develop blood cancer/geriatric syndrome/illness/cardiovascular diseaseEstimated to be 10 years

    -Individuals with mutations will be followed longitudinally to monitor the fraction of hematopoietic cells with mutations, the functional consequences of mutations in their blood cells, and the risk of developing a blood cancer, geriatric syndrome, cardiovascular disease, or other illness.

  • Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutationsEstimated to be 10 years
  • Determine whether expansion of clonal hematopoiesis (CH) occurs following acute traumaEstimated to be 10 years

    -Measures change in variant allele fraction