Aging, Geriatric Syndromes and Clonal Hematopoiesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
Participants seen in Washington University School of Medicine clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cognitive Assessment
Other intervention-Baseline and no more frequently than every 6 months until death
Activities of Daily Living Questionnaire
Other intervention* 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 intervention* 7 items about daily functional status * Baseline and no more frequently than every 6 months until death
Karnofsky Self-reported Performance Rating Scale
Other intervention* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
Number of Falls
Other intervention* 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 intervention* 13 items about comorbidity * Baseline and no more frequently than every 6 months until death
MOS Social Activity Survey
Other intervention* 4 items about social activity * Baseline and no more frequently than every 6 months until death
Unintentional Weight Loss
Other intervention* 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 intervention* 7 items about heart health and smoking history * Baseline and no more frequently than every 6 months until death
Gait Speed
Other intervention* Research coordinator will test gait speed * Baseline and no more frequently than every 6 months until death
Grip Strength
Other intervention* Research coordinator will test grip strength * Baseline and no more frequently than every 6 months until death
Height and Weight measurements
Other intervention-Baseline and no more frequently than every 6 months until death
Blood pressure measurement
Other intervention-Baseline and no more frequently than every 6 months until death
Optional bone marrow biopsy
Procedure/Surgery-1 optional bone marrow biopsy
Blood draw for trauma measurements
Procedure/Surgery-For Arm E only
Femur head donation
Other interventionHip replacement participants only
Knee bone fragments
Other interventionKnee replacement participants only
Bone marrow aspirate
Other interventionHip and knee replacement participants only
Treatment groups
2,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Arm A: Clonal hematopoiesis16 interventions
Group B: Arm B: No clonal hematopoiesis16 interventions
Group C: Arm C: No clonal hematopoiesis & no follow-up15 interventions
Group D: Arm D: Hip replacement2 interventions
Group E: Arm E: Trauma1 intervention
Group F: Arm F: Knee replacement2 interventions
Trial outcomes
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
-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.
Time frame
Estimated to be 10 years2
Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations
-The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals.
Time frame
Estimated to be 10 years3
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
-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.
Time frame
Estimated to be 10 years4
Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations
Time frame
Estimated to be 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Edward P. Evans Foundation
Collaborator
Source ClinicalTrials.gov