Aging, Geriatric Syndromes and Clonal Hematopoiesis
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
April 25, 2025
April 1, 2025
14.1 years
November 9, 2015
April 24, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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.
Estimated to be 10 years
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.
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
-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
Estimated to be 10 years
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
-Measures change in variant allele fraction
Estimated to be 10 years
Study Arms (5)
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
* 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. * Participants with or without clonal hematopoiesis who are undergoing hip replacement * 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 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.
Interventions
-Baseline and no more frequently than every 6 months until death
* 10 items about daily functional status * Baseline and no more frequently than every 6 months until death
* 7 items about daily functional status * Baseline and no more frequently than every 6 months until death
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
* 13 items about comorbidity * Baseline and no more frequently than every 6 months until death
* 4 items about social activity * Baseline and no more frequently than every 6 months until death
* 2 items about nutrition * Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
* 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
* 7 items about heart health and smoking history * Baseline and no more frequently than every 6 months until death
* Research coordinator will test gait speed * Baseline and no more frequently than every 6 months until death
* Research coordinator will test grip strength * Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
-1 optional bone marrow biopsy
Eligibility Criteria
Participants seen in Washington University School of Medicine clinics.
You may qualify if:
- 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)
You may not qualify if:
- Inability or unwillingness to complete health questionnaire.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
Biospecimen
* Peripheral blood * Buccal swab or tongue brushing * Optional bone marrow biopsy
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meagan Jacoby, M.D.
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 13, 2015
Study Start
March 10, 2016
Primary Completion (Estimated)
April 30, 2030
Study Completion (Estimated)
April 30, 2030
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share