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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02604563
Other study ID # 201511019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2016
Est. completion date April 30, 2030

Study information

Verified date April 2024
Source Washington University School of Medicine
Contact Meagan Jacoby, M.D.
Phone 314-747-8439
Email mjacoby@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date April 30, 2030
Est. primary completion date April 30, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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. - 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


Intervention

Other:
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
Genetic:
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
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
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
Procedure:
Optional bone marrow biopsy
-1 optional bone marrow biopsy
Blood draw for trauma measurements
-For Arm E only

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine Edward P. Evans Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations Estimated to be 10 years
Primary Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma -Measures change in variant allele fraction Estimated to be 10 years
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