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Immunological Characterization of Blood of Normal Individuals

NCT ID: NCT01386892

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-01

Study Completion Date

2015-01-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heathly Volunteers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteer

Healthy Volunteer without lung disease

No intervention

Intervention Type OTHER

There is no intervention for this study

Interventions

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No intervention

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clay Marsh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2011H0007

Identifier Type: -

Identifier Source: org_study_id