GeriatricsNCT02604563
Aging, Geriatric Syndromes and Clonal Hematopoiesis
An observational study of Geriatrics and Aged, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatrics, Aged, Geriatric Syndromes
- What is being tested?
- Cognitive Assessment, Activities of Daily Living Questionnaire and Instrumental Activities of Daily Living, subscale of the OARS
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2016to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants seen in Washington University School of Medicine clinics.
Who may be able to join
- 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)
Who cannot join
- 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.
- Vulnerable populations (e.g. prisoners).
- Known infection with Hepatitis B or C, HTLV, or HIV.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Meagan Jacoby, M.D., 314-747-8439, mjacoby@wustl.edu
Kristi Williams, B.S., 314-362-6963, kjw1@wustl.edu
About this study
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.
- Conditions
- Geriatrics, Aged, Geriatric Syndromes, Cardiovascular Diseases
- Being tested
- Cognitive Assessment, Activities of Daily Living Questionnaire, Instrumental Activities of Daily Living, subscale of the OARS, Karnofsky Self-reported Performance Rating Scale, Number of Falls
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive AssessmentOther
-Baseline and no more frequently than every 6 months until death
Activities of Daily Living QuestionnaireOther
- 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 OARSOther
- 7 items about daily functional status
- Baseline and no more frequently than every 6 months until death
Karnofsky Self-reported Performance Rating ScaleOther
- 1 item about daily functional status
- Baseline and no more frequently than every 6 months until death
Number of FallsOther
- 1 item about daily functional status
- Baseline and no more frequently than every 6 months until death
Physical Health Section, subscale of the OARSOther
- 13 items about comorbidity
- Baseline and no more frequently than every 6 months until death
MOS Social Activity SurveyOther
- 4 items about social activity
- Baseline and no more frequently than every 6 months until death
Unintentional Weight LossOther
- 2 items about nutrition
- Baseline and no more frequently than every 6 months until death
Peripheral Blood DrawGenetic
-Baseline and no more frequently than every 6 months until death
Buccal SwabGenetic
- 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 questionnaireOther
- 7 items about heart health and smoking history
- Baseline and no more frequently than every 6 months until death
Gait SpeedOther
- Research coordinator will test gait speed
- Baseline and no more frequently than every 6 months until death
Grip StrengthOther
- Research coordinator will test grip strength
- Baseline and no more frequently than every 6 months until death
Height and Weight measurementsOther
-Baseline and no more frequently than every 6 months until death
Blood pressure measurementOther
-Baseline and no more frequently than every 6 months until death
Optional bone marrow biopsyProcedure or surgery
-1 optional bone marrow biopsy
Blood draw for trauma measurementsProcedure or surgery
-For Arm E only
Femur head donationOther
Hip replacement participants only
Knee bone fragmentsOther
Knee replacement participants only
Bone marrow aspirateOther
Hip and knee replacement participants only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cognitive Assessment; Other: Activities of Daily Living Questionnaire; Other: Instrumental Activities of Daily Living, subscale of the OARS; Other: Karnofsky Self-reported Performance Rating Scale; Other: Number of Falls; Other: Physical Health Section, subscale of the OARS; Other: MOS Social Activity Survey; Other: Unintentional Weight Loss; Genetic: Peripheral Blood Draw; Genetic: Buccal Swab; Other: Heart Health and Smoking History from BRFSS questionnaire; Other: Gait Speed; Other: Grip Strength; Other: Height and Weight measurements; Other: Blood pressure measurement; Procedure: 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 Receives: Other: Cognitive Assessment; Other: Activities of Daily Living Questionnaire; Other: Instrumental Activities of Daily Living, subscale of the OARS; Other: Karnofsky Self-reported Performance Rating Scale; Other: Number of Falls; Other: Physical Health Section, subscale of the OARS; Other: MOS Social Activity Survey; Other: Unintentional Weight Loss; Genetic: Peripheral Blood Draw; Genetic: Buccal Swab; Other: Heart Health and Smoking History from BRFSS questionnaire; Other: Gait Speed; Other: Grip Strength; Other: Height and Weight measurements; Other: Blood pressure measurement; Procedure: 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 Receives: Other: Cognitive Assessment; Other: Activities of Daily Living Questionnaire; Other: Instrumental Activities of Daily Living, subscale of the OARS; Other: Karnofsky Self-reported Performance Rating Scale; Other: Number of Falls; Other: Physical Health Section, subscale of the OARS; Other: MOS Social Activity Survey; Other: Unintentional Weight Loss; Genetic: Peripheral Blood Draw; Genetic: Buccal Swab; Other: Heart Health and Smoking History from BRFSS questionnaire; Other: Gait Speed; Other: Grip Strength; Other: Height and Weight measurements; Other: Blood pressure measurement | |
| Arm D: Hip replacement | -Participants undergoing a hip replacement will be asked to donate their femur head or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures. Receives: Other: Femur head donation; Other: Bone marrow aspirate | |
| 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. Receives: Procedure: Blood draw for trauma measurements | |
| Arm F: Knee replacement | Participants undergoing a knee replacement will be asked to donate their [SU1.1]bone fragments or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures. Receives: Other: Knee bone fragments; Other: Bone marrow aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
Measured: Estimated to be 10 years
Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations
Measured: Estimated to be 10 years
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
-Measures change in variant allele fraction
Measured: Estimated to be 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start10 Mar 2016
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Edward P. Evans Foundation
- Responsible party
- Sponsor
- Investigators
- Meagan Jacoby, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604563
- Sponsor's protocol ID
- 201511019
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2015
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging, Geriatric Syndromes and Clonal Hematopoiesis
- ClinicalTrials.gov ID
- NCT02604563
- Acronym / sponsor ID
- 201511019
- Conditions
- Geriatrics, Aged, Geriatric Syndromes, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Edward P. Evans Foundation
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: Clonal hematopoiesis | – | Other: Cognitive Assessment, Other: Activities of Daily Living Questionnaire, Other: Instrumental Activities of Daily Living, subscale of the OARS, Other: Karnofsky Self-reported Performance Rating Scale, Other: Number of Falls, Other: Physical Health Section, subscale of the OARS, Other: MOS Social Activity Survey, Other: Unintentional Weight Loss, Genetic: Peripheral Blood Draw, Genetic: Buccal Swab, Other: Heart Health and Smoking History from BRFSS questionnaire, Other: Gait Speed, Other: Grip Strength, Other: Height and Weight measurements, Other: Blood pressure measurement, Procedure: Optional bone marrow biopsy* 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 | – | Other: Cognitive Assessment, Other: Activities of Daily Living Questionnaire, Other: Instrumental Activities of Daily Living, subscale of the OARS, Other: Karnofsky Self-reported Performance Rating Scale, Other: Number of Falls, Other: Physical Health Section, subscale of the OARS, Other: MOS Social Activity Survey, Other: Unintentional Weight Loss, Genetic: Peripheral Blood Draw, Genetic: Buccal Swab, Other: Heart Health and Smoking History from BRFSS questionnaire, Other: Gait Speed, Other: Grip Strength, Other: Height and Weight measurements, Other: Blood pressure measurement, Procedure: Optional bone marrow biopsy* 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 | – | Other: Cognitive Assessment, Other: Activities of Daily Living Questionnaire, Other: Instrumental Activities of Daily Living, subscale of the OARS, Other: Karnofsky Self-reported Performance Rating Scale, Other: Number of Falls, Other: Physical Health Section, subscale of the OARS, Other: MOS Social Activity Survey, Other: Unintentional Weight Loss, Genetic: Peripheral Blood Draw, Genetic: Buccal Swab, Other: Heart Health and Smoking History from BRFSS questionnaire, Other: Gait Speed, Other: Grip Strength, Other: Height and Weight measurements, Other: Blood pressure measurement* 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 | – | Other: Femur head donation, Other: Bone marrow aspirate-Participants undergoing a hip replacement will be asked to donate their femur head or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures. |
| Arm E: Trauma | – | Procedure: Blood draw for trauma measurements-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. |
| Arm F: Knee replacement | – | Other: Knee bone fragments, Other: Bone marrow aspirateParticipants undergoing a knee replacement will be asked to donate their [SU1.1]bone fragments or bone marrow aspirate that would otherwise be discarded for cell harvesting/banking and DNA sequencing. They are not required to complete any other study procedures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants seen in Washington University School of Medicine clinics.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
- Vulnerable populations (e.g. prisoners).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Assessment-Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Activities of Daily Living Questionnaire* 10 items about daily functional status * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| 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 | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Karnofsky Self-reported Performance Rating Scale* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Number of Falls* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Physical Health Section, subscale of the OARS* 13 items about comorbidity * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| MOS Social Activity Survey* 4 items about social activity * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Unintentional Weight Loss* 2 items about nutrition * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Peripheral Blood Draw-Baseline and no more frequently than every 6 months until death | Genetic | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| 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 | Genetic | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| 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 | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Gait Speed* Research coordinator will test gait speed * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Grip Strength* Research coordinator will test grip strength * Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Height and Weight measurements-Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Blood pressure measurement-Baseline and no more frequently than every 6 months until death | Other | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis, Arm C: No clonal hematopoiesis & no follow-up |
| Optional bone marrow biopsy-1 optional bone marrow biopsy | Procedure or surgery | Arm A: Clonal hematopoiesis, Arm B: No clonal hematopoiesis |
| Blood draw for trauma measurements-For Arm E only | Procedure or surgery | Arm E: Trauma |
| Femur head donationHip replacement participants only | Other | Arm D: Hip replacement |
| Knee bone fragmentsKnee replacement participants only | Other | Arm F: Knee replacement |
| Bone marrow aspirateHip and knee replacement participants only | Other | Arm D: Hip replacement, Arm F: Knee replacement |
Primary outcome
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
-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.
Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations
Time frame: Estimated to be 10 years
-The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals.
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
Time frame: Estimated to be 10 years
-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.
Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations
Time frame: Estimated to be 10 years
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
Time frame: Estimated to be 10 years
-Measures change in variant allele fraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meagan Jacoby, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics and Aged, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meagan Jacoby, M.D. (314-747-8439, mjacoby@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.