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NCT Number: NCT02604563

Aging, Geriatric Syndromes and Clonal Hematopoiesis

In this study the investigators will incorporate a wide range of clinical variables associated with aging and cardiovascular disease to determine whether they are associated with mutation status independent of chronologic age. Clinically, aging can be operationalized using geriatric assessment, which entails a comprehensive multi-dimensional assessment of the health of an older adult, including measures of comorbidity, polypharmacy, functional status, cognition, depression, falls, social activities and social support. Given that aging is heterogeneous, geriatric assessment allows greater specificity for aging than chronological age alone.

Recruiting

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Key information

Conditions

Geriatrics Aged Cardiovascular Diseases Geriatric Syndromes

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Eric Duncavage, M.D.

SUB_INVESTIGATOR

Kelly Bolton, M.D., Ph.D.

SUB_INVESTIGATOR

Kristi Williams, B.S.

CONTACT

[email protected]

314-362-6963

Meagan Jacoby, M.D.

CONTACT

[email protected]

314-747-8439

Meagan Jacoby, M.D.

PRINCIPAL_INVESTIGATOR

Timothy Ley, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Cognitive Assessment

Other

-Baseline and no more frequently than every 6 months until death

Activities of Daily Living Questionnaire

Other
  • 10 items about daily functional status
  • Baseline and no more frequently than every 6 months until death

Instrumental Activities of Daily Living, subscale of the OARS

Other
  • 7 items about daily functional status
  • Baseline and no more frequently than every 6 months until death

Karnofsky Self-reported Performance Rating Scale

Other
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death

Number of Falls

Other
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death

Physical Health Section, subscale of the OARS

Other
  • 13 items about comorbidity
  • Baseline and no more frequently than every 6 months until death

MOS Social Activity Survey

Other
  • 4 items about social activity
  • Baseline and no more frequently than every 6 months until death

Unintentional Weight Loss

Other
  • 2 items about nutrition
  • Baseline and no more frequently than every 6 months until death

Peripheral Blood Draw

Genetic

-Baseline and no more frequently than every 6 months until death

buccal swab

Genetic
  • Participants will rinse their mouths 2 times with water for 20-30 seconds and discard the expectorated sample. One side of the inner cheek (buccal mucosa) will then be scraped with a cotton swab 20 times (alternatively, the tongue will be brushed 20 times with a toothbrush)
  • Baseline and no more frequently than every 6 months until death

Heart Health and Smoking History from BRFSS questionnaire

Other
  • 7 items about heart health and smoking history
  • Baseline and no more frequently than every 6 months until death

Gait Speed

Other
  • Research coordinator will test gait speed
  • Baseline and no more frequently than every 6 months until death

Grip Strength

Other
  • Research coordinator will test grip strength
  • Baseline and no more frequently than every 6 months until death

Height and Weight measurements

Other

-Baseline and no more frequently than every 6 months until death

Blood pressure measurement

Other

-Baseline and no more frequently than every 6 months until death

Optional bone marrow biopsy

Procedure

-1 optional bone marrow biopsy

Blood draw for trauma measurements

Procedure

-For Arm E only

Femur head donation

Other

Hip replacement participants only

Knee bone fragments

Other

Knee replacement participants only

Bone marrow aspirate

Other

Hip and knee replacement participants only

Primary outcomes

  1. 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

    Time frame: Estimated 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.

  2. Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations

    Time frame: Estimated to be 10 years

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

  3. Determine the natural history of mutations in older adults with clonal hematopoiesis as measured by risk to develop blood cancer/geriatric syndrome/illness/cardiovascular disease

    Time frame: Estimated 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.

  4. Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations

    Time frame: Estimated to be 10 years

  5. Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma

    Time frame: Estimated to be 10 years

    -Measures change in variant allele fraction

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Williams, B.S.

CONTACT

[email protected]

314-362-6963

Meagan Jacoby, M.D.

CONTACT

[email protected]

314-747-8439

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Edward P. Evans Foundation

Registry information

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Nov 13, 2015
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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