NCT02604563招募中不适用
Aging, Geriatric Syndromes and Clonal Hematopoiesis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
- •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.
研究组 & 干预措施
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
干预措施: Cognitive Assessment (Other)
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
干预措施: Activities of Daily Living Questionnaire (Other)
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
干预措施: Instrumental Activities of Daily Living, subscale of the OARS (Other)
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
干预措施: Karnofsky Self-reported Performance Rating Scale (Other)
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
干预措施: Number of Falls (Other)
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
干预措施: Physical Health Section, subscale of the OARS (Other)
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
干预措施: MOS Social Activity Survey (Other)
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
干预措施: Unintentional Weight Loss (Other)
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
干预措施: Peripheral Blood Draw (Genetic)
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
干预措施: Buccal Swab (Genetic)
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
干预措施: Heart Health and Smoking History from BRFSS questionnaire (Other)
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
干预措施: Gait Speed (Other)
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
干预措施: Grip Strength (Other)
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
干预措施: Blood pressure measurement (Other)
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
干预措施: Optional bone marrow biopsy (Procedure)
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
干预措施: Cognitive Assessment (Other)
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
干预措施: Activities of Daily Living Questionnaire (Other)
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
干预措施: Instrumental Activities of Daily Living, subscale of the OARS (Other)
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
干预措施: Karnofsky Self-reported Performance Rating Scale (Other)
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
干预措施: Number of Falls (Other)
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
干预措施: Physical Health Section, subscale of the OARS (Other)
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
干预措施: MOS Social Activity Survey (Other)
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
干预措施: Unintentional Weight Loss (Other)
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
干预措施: Peripheral Blood Draw (Genetic)
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
干预措施: Buccal Swab (Genetic)
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
干预措施: Heart Health and Smoking History from BRFSS questionnaire (Other)
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
干预措施: Gait Speed (Other)
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
干预措施: Grip Strength (Other)
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
干预措施: Height and Weight measurements (Other)
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
干预措施: Blood pressure measurement (Other)
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
干预措施: Optional bone marrow biopsy (Procedure)
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
干预措施: Cognitive Assessment (Other)
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
干预措施: Activities of Daily Living Questionnaire (Other)
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
干预措施: Instrumental Activities of Daily Living, subscale of the OARS (Other)
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
干预措施: Karnofsky Self-reported Performance Rating Scale (Other)
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
干预措施: Number of Falls (Other)
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
干预措施: Physical Health Section, subscale of the OARS (Other)
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
干预措施: MOS Social Activity Survey (Other)
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
干预措施: Unintentional Weight Loss (Other)
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
干预措施: Peripheral Blood Draw (Genetic)
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
干预措施: Buccal Swab (Genetic)
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
干预措施: Heart Health and Smoking History from BRFSS questionnaire (Other)
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
干预措施: Gait Speed (Other)
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
干预措施: Grip Strength (Other)
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
干预措施: Height and Weight measurements (Other)
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
干预措施: Blood pressure measurement (Other)
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.
干预措施: Femur head donation (Other)
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.
干预措施: Blood draw for trauma measurements (Procedure)
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.
干预措施: Bone marrow aspirate (Other)
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.
干预措施: Bone marrow aspirate (Other)
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.
干预措施: Knee bone fragments (Other)
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
干预措施: Height and Weight measurements (Other)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Estimated to be 10 years
Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma
时间窗: Estimated to be 10 years
-Measures change in variant allele fraction
次要结局
未报告次要终点
研究者
研究点 (2)
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