Recruiting

Observational StudyAging, Geriatric Syndromes and Clonal Hematopoiesis

Sponsor:

Washington University School of Medicine

Code:

NCT02604563

Conditions

Geriatrics

Aged

Geriatric Syndromes

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Cognitive Assessment

Activities of Daily Living Questionnaire

Instrumental Activities of Daily Living, subscale of the OARS

Karnofsky Self-reported Performance Rating Scale

Number of Falls

Study Details

Brief summary:

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.

Conditions

Geriatrics

Aged

Geriatric Syndromes

Cardiovascular Diseases

Study ID

NCT02604563

Start date

Mar 10, 2016

Status verified date

Jul, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

Arm D: Hip replacement

-Participants undergoing a hip replacement will be asked to donate their femur head or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures.

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.

Arm F: Knee replacement

Participants undergoing a knee replacement will be asked to donate their \[SU1.1\]bone fragments or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures.

Interventions

Cognitive Assessment

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

Activities of Daily Living Questionnaire

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

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

Karnofsky Self-reported Performance Rating Scale

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

Number of Falls

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

Physical Health Section, subscale of the OARS

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

MOS Social Activity Survey

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

Unintentional Weight Loss

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

Peripheral Blood Draw

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

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

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

Gait Speed

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

Grip Strength

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

Height and Weight measurements

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

Blood pressure measurement

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

Optional bone marrow biopsy

-1 optional bone marrow biopsy

Blood draw for trauma measurements

-For Arm E only

Femur head donation

Hip replacement participants only

Knee bone fragments

Knee replacement participants only

Bone marrow aspirate

Hip and knee replacement participants only

Primary outcome measure

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 ]
Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations [ Time Frame: 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 ]
Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations [ Time Frame: Estimated to be 10 years ]
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma [ Time Frame: Estimated to be 10 years ]

Central Contacts and Locations

Central contacts

Meagan Jacoby, M.D.

314-747-8439 mjacoby@wustl.edu

Kristina Williams, B.S.

314-362-6963 kjw1@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Meagan Jacoby, M.D.

314-747-8439 mjacoby@wustl.edu

Kristi Williams, B.S.

314-362-6963 kjw1@wustl.edu

Principal Investigator:

Meagan Jacoby, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-13.