Clinical trial NCT02604563: Aging, Geriatric Syndromes and Clonal Hematopoiesis
Official title: Aging, Geriatric Syndromes and Clonal Hematopoiesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Geriatrics
Aged
Geriatric Syndromes
Cardiovascular Diseases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Edward P. Evans Foundation
First posted: 2015-11-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants seen in Washington University School of Medicine clinics.

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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Estimated to be 10 years
measure: Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations
timeFrame: Estimated to be 10 years
measure: 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
timeFrame: Estimated to be 10 years
measure: Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations
timeFrame: Estimated to be 10 years
measure: Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
timeFrame: Estimated to be 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Meagan Jacoby, M.D.
role: PRINCIPAL_INVESTIGATOR
References: