Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
2000 participants
OBSERVATIONAL
2016-03-10
2030-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Research on Aging Project in Iceland: Second Stage
NCT01322568
Age-Related Changes in Body Composition
NCT01517113
Human Phenotype Project Study Protocol
NCT05817734
COV2Base-A Rare Disease by COVID Study
NCT04564274
Epidemiology of APO- and Lipoproteins in Elderly Women
NCT00005223
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
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
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
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
No interventions assigned to this group
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.
Blood draw for trauma measurements
-For Arm E only
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edward P. Evans Foundation
OTHER
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Meagan Jacoby, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201511019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.