Immunological Characterization of Blood of Normal Individuals

The Ohio State University

Status: Completed

Conditions: Heathly Volunteers

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT01386892

2011H0007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,300 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,300 participants in 1 patient group

Healthy Volunteer

Description:

Healthy Volunteer without lung disease

Treatment:

Other: No intervention