Aging, Geriatric Syndromes and Clonal Hematopoiesis

Conditions

• Aged
• Cardiovascular Diseases
• Geriatric Syndromes
• Geriatrics

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Mar 10, 2016

Status verified

May 2026

Primary completion

Apr 30, 2030

Completion

Apr 30, 2030

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: 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: 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: 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: 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.
• Arm: 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.

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 ]

Central Contacts

• Meagan Jacoby, M.D.
  314-747-8439
  [email protected]
• Kristina Williams, B.S.
  314-362-6963
  [email protected]

Locations (1)

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