Aging, Geriatric Syndromes and Clonal Hematopoiesis

Recruiting

• Conditions: Geriatrics; Aged; Geriatric Syndromes; Cardiovascular Diseases

• Registration Number: NCT02604563
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Study Start: 2016-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.
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	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 geriatric syndromes as measured by hematopoietic stem cell mutations	Estimated to be 10 years	-The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals.
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	Estimated to be 10 years	-Measures change in variant allele fraction

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States