Aging, Geriatric Syndromes and Clonal Hematopoiesis

May 7, 2026 updated by: Washington University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Kristina Williams, B.S.
  • Phone Number: 314-362-6963
  • Email: kjw1@wustl.edu

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
          • Kristi Williams, B.S.
          • Phone Number: 314-362-6963
          • Email: kjw1@wustl.edu
        • Principal Investigator:
          • Meagan Jacoby, M.D.
        • Sub-Investigator:
          • Eric Duncavage, M.D.
        • Sub-Investigator:
          • Kelly Bolton, M.D., Ph.D.
        • Sub-Investigator:
          • Matthew Walter, M.D.
        • Sub-Investigator:
          • Timothy Ley, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants seen in Washington University School of Medicine clinics.

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Arm A: Clonal hematopoiesis
  • Complete several self-administered health assessments at baseline and every 6 months until death.
  • Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline and every 6 months until death.
  • Peripheral blood draw will occur at baseline and no more than every 6 months until death.
  • Buccal swabs will occur at baseline and repeated as necessary, but not more than every 6 months until death
  • May be approached about optional bone marrow biopsy
Other: Cognitive Assessment
-Baseline and no more frequently than every 6 months until death
Other: Activities of Daily Living Questionnaire
  • 10 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Instrumental Activities of Daily Living, subscale of the OARS
  • 7 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Karnofsky Self-reported Performance Rating Scale
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Number of Falls
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Physical Health Section, subscale of the OARS
  • 13 items about comorbidity
  • Baseline and no more frequently than every 6 months until death
Other: MOS Social Activity Survey
  • 4 items about social activity
  • Baseline and no more frequently than every 6 months until death
Other: Unintentional Weight Loss
  • 2 items about nutrition
  • Baseline and no more frequently than every 6 months until death
Genetic: Peripheral Blood Draw
-Baseline and no more frequently than every 6 months until death
Genetic: Buccal Swab
  • 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
Other: Heart Health and Smoking History from BRFSS questionnaire
  • 7 items about heart health and smoking history
  • Baseline and no more frequently than every 6 months until death
Other: Gait Speed
  • Research coordinator will test gait speed
  • Baseline and no more frequently than every 6 months until death
Other: Grip Strength
  • Research coordinator will test grip strength
  • Baseline and no more frequently than every 6 months until death
Other: Height and Weight measurements
-Baseline and no more frequently than every 6 months until death
Other: Blood pressure measurement
-Baseline and no more frequently than every 6 months until death
Procedure: Optional bone marrow biopsy
-1 optional bone marrow biopsy
Arm B: No clonal hematopoiesis
  • Complete several self-administered health assessments at baseline and every 6 months until death.
  • Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline and every 6 months until death.
  • Peripheral blood draw will occur at baseline and no more than every 6 months until death.
  • Buccal swabs will occur at baseline and repeated as necessary, but not more than every 6 months until death
  • May be approached about optional bone marrow biopsy
Other: Cognitive Assessment
-Baseline and no more frequently than every 6 months until death
Other: Activities of Daily Living Questionnaire
  • 10 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Instrumental Activities of Daily Living, subscale of the OARS
  • 7 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Karnofsky Self-reported Performance Rating Scale
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Number of Falls
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Physical Health Section, subscale of the OARS
  • 13 items about comorbidity
  • Baseline and no more frequently than every 6 months until death
Other: MOS Social Activity Survey
  • 4 items about social activity
  • Baseline and no more frequently than every 6 months until death
Other: Unintentional Weight Loss
  • 2 items about nutrition
  • Baseline and no more frequently than every 6 months until death
Genetic: Peripheral Blood Draw
-Baseline and no more frequently than every 6 months until death
Genetic: Buccal Swab
  • 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
Other: Heart Health and Smoking History from BRFSS questionnaire
  • 7 items about heart health and smoking history
  • Baseline and no more frequently than every 6 months until death
Other: Gait Speed
  • Research coordinator will test gait speed
  • Baseline and no more frequently than every 6 months until death
Other: Grip Strength
  • Research coordinator will test grip strength
  • Baseline and no more frequently than every 6 months until death
Other: Height and Weight measurements
-Baseline and no more frequently than every 6 months until death
Other: Blood pressure measurement
-Baseline and no more frequently than every 6 months until death
Procedure: Optional bone marrow biopsy
-1 optional bone marrow biopsy
Arm C: No clonal hematopoiesis & no follow-up
  • Complete several self-administered health assessments at baseline with no further follow-up
  • Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline with no further follow-up
  • Peripheral blood draw will occur at baseline with no further follow-up
  • Buccal swabs will occur at baseline with no further follow-up
Other: Cognitive Assessment
-Baseline and no more frequently than every 6 months until death
Other: Activities of Daily Living Questionnaire
  • 10 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Instrumental Activities of Daily Living, subscale of the OARS
  • 7 items about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Karnofsky Self-reported Performance Rating Scale
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Number of Falls
  • 1 item about daily functional status
  • Baseline and no more frequently than every 6 months until death
Other: Physical Health Section, subscale of the OARS
  • 13 items about comorbidity
  • Baseline and no more frequently than every 6 months until death
Other: MOS Social Activity Survey
  • 4 items about social activity
  • Baseline and no more frequently than every 6 months until death
Other: Unintentional Weight Loss
  • 2 items about nutrition
  • Baseline and no more frequently than every 6 months until death
Genetic: Peripheral Blood Draw
-Baseline and no more frequently than every 6 months until death
Genetic: Buccal Swab
  • 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
Other: Heart Health and Smoking History from BRFSS questionnaire
  • 7 items about heart health and smoking history
  • Baseline and no more frequently than every 6 months until death
Other: Gait Speed
  • Research coordinator will test gait speed
  • Baseline and no more frequently than every 6 months until death
Other: Grip Strength
  • Research coordinator will test grip strength
  • Baseline and no more frequently than every 6 months until death
Other: Height and Weight measurements
-Baseline and no more frequently than every 6 months until death
Other: Blood pressure measurement
-Baseline and no more frequently than every 6 months until death
Arm E: Trauma
-Blood sample at the time of admission with initial bloodwork. For inpatient participants, weekly follow-up samples will be drawn with morning phlebotomy. A follow-up sample collection will occur 4-7 weeks after discharge.
Procedure: Blood draw for trauma measurements
-For Arm E only
Arm D: Hip replacement
-Participants undergoing a hip replacement will be asked to donate their femur head that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures.
Other: Femur head donation
Hip replacement participants only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Estimated to be 10 years
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.
Estimated to be 10 years
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.
Estimated to be 10 years
Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations
Time Frame: Estimated to be 10 years
Estimated to be 10 years
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
Time Frame: Estimated to be 10 years
-Measures change in variant allele fraction
Estimated to be 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Edward P. Evans Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meagan Jacoby, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201511019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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Locations

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