Clinical trial NCT01386892: Immunological Characterization of Blood of Normal Individuals
Official title: Immunological Characterization of Blood of Normal Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heathly Volunteers
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2011-07-01
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood content differences between the lung disease and healthy control populations
timeFrame: Day 1
Secondary outcomes:
measure: Genetic expression of relevant genes between the lung disease and healthy control populations
timeFrame: Day 1
measure: Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
timeFrame: Day 1
measure: Identify diagnostic and prognostic indicators for lung disease
timeFrame: December 2020
measure: Develop possible treatment for lung disease
timeFrame: December 2020
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Clay Marsh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: