Immunological Characterization of Blood of Normal Individuals
2021年11月1日 更新者：Ohio State University
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
1300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Participants may also be recruited by word of mouth or via public advertising.
This study is open to all eligibile healthy adult volunteers regardless of gender, age and ethnicity.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Healthy Volunteer
Healthy Volunteer without lung disease
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这项研究没有干预
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood content differences between the lung disease and healthy control populations
大体时间：Day 1
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Test for differences in the blood of individuals with lung disease and normal healthy controls.
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Genetic expression of relevant genes between the lung disease and healthy control populations
大体时间：Day 1
|
Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.
|
Day 1
|
|
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
大体时间：Day 1
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Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.
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Day 1
|
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Identify diagnostic and prognostic indicators for lung disease
大体时间：December 2020
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Develop and test possible diagnostic and prognostic indicators for various lung diseases.
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December 2020
|
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Develop possible treatment for lung disease
大体时间：December 2020
|
Develop and test possible reprogramming of blood cells to promote vessel formation as a way to prevent tumor metastases and modify the progression of specific lung diseases.
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December 2020
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Clay Marsh, M.D.、Ohio State University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年3月1日
初级完成 (实际的)
2015年1月5日
研究完成 (实际的)
2015年1月5日
研究注册日期
首次提交
2011年4月27日
首先提交符合 QC 标准的
2011年6月30日
首次发布 (估计)
2011年7月1日
研究记录更新
最后更新发布 (实际的)
2021年11月8日
上次提交的符合 QC 标准的更新
2021年11月1日
最后验证
2021年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 2011H0007
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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