A Prospective, Non-Randomized, Multi-Center Observational Study to Establish a Physical Baseline Profile for Individual Study Subjects Using Various Modalities and Identify Deviations Via Longitudinal Monitoring That May Develop Over Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Biomarkers that exhibit significant change
研究概览
简要总结
This is a minimal risk, prospective, non-randomized, multi-center population based observational study to establish a physical baseline profile for individual study subjects using various modalities (blood draws, non-invasive imaging, stool samples, saliva samples) and identify deviations through longitudinal monitoring that may develop over time and may be relevant to human health and healthy longevity.
详细描述
The two key elements of the PUER Research protocol include (1) molecular and laboratory profiling and (2) non-invasive imaging and wearables/ "quantified self" measurements. All elements are optional. Molecular assessments will be conducted using peripheral blood samples, and potentially urine, stool or saliva samples. Non-invasive imaging assessment will consist of magnetic resonance imaging (MRI) and computerized tomography (CT) scans, ultrasound, and x-ray. All imaging modalities are optional. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables, may also be conducted and are optional.
The study will result in longitudinal data collection to inform if any modalities employed here can inform of baseline deviations for individuals. Researchers at study sites will not be blinded to the data being collected during this study.
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
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female; age 18 to 90
- •Absence or presence of any medical history or any signs or symptoms of any disease
- •Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits
排除标准
- •Unwillingness or inability to participate in the study
- •Unwillingness or inability to provide written Informed Consent Form
- •WOCBP with positive pregnancy test at enrollment or at any visit
结局指标
主要结局
Biomarkers that exhibit significant change
时间窗: 12 Months
The number of biomarkers that exhibit significant change from baseline to any follow-up timepoint, if obtained.
次要结局
未报告次要终点
