Aging, Geriatric Syndromes and Clonal Hematopoiesis | NCT02604563

NCT02604563

Status Module

Sponsor/Collaborators Module

Name	Class
Edward P. Evans Foundation	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Assessment	Other	-Baseline and no more frequently than every 6 months until death	Arm A: Clonal hematopoiesis Arm B: No clonal hematopoiesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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	-Measures change in variant allele fraction	Estimated to be 10 years

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Meagan Jacoby, M.D.	Contact	314-747-8439		mjacoby@wustl.edu
Kristina Williams, B.S.	Contact	314-362-6963		kjw1@wustl.edu

Name	Affiliation	Role
Meagan Jacoby, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine	Recruiting	St Louis	Missouri	63110	United States

References Module

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

IPD Sharing Statement Module

Results Section

No data available