Immunological Characterization of Blood of Normal Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Blood content differences between the lung disease and healthy control populations
研究概览
简要总结
This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for other approved protocols and for analysis. These include determination of the functional capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine will have similar testing which may also be compared to the blood testing results. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of normal volunteers and compare it to immune function in disease states.
详细描述
Blood will be obtained via peripheral venipuncture. The blood will be divided into components (e.g. plasma, serum, microvesicles, and cells) then analyzed. Flow cytometry will be used to determine cell and microvesicle subsets. RNA will be extracted from the various components of blood and will be subjected to gene and microRNA profiling to determine gene expression. DNA will be isolated from the cells to be used in studies investigating epigenetic regulation of genes identified in the screens. Protein will also be isolated from the multiple components to examine the impact of genetic regulation by epigenetic mechanisms or microRNA on protein expression. Peripheral blood mononuclear cells will be placed in tissue culture for study.
Saliva and urine will be obtained the same day as blood for testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
- •At least 18 years or older.
- •Are capable of reading, understanding and providing written informed consent.
排除标准
- •Non-English speaking.
- •Individuals under 18 years old.
- •Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
- •Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
- •Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
- •Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.
结局指标
主要结局
Blood content differences between the lung disease and healthy control populations
时间窗: Day 1
Test for differences in the blood of individuals with lung disease and normal healthy controls.
次要结局
- Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.(Day 1)
- Develop possible treatment for lung disease(December 2020)
- Genetic expression of relevant genes between the lung disease and healthy control populations(Day 1)
- Identify diagnostic and prognostic indicators for lung disease(December 2020)