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Immunological Characterization of Blood of Normal Individuals

Immunological Characterization of Blood of Normal Individuals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01386892
Enrollment
1300
Registered
2011-07-01
Start date
2011-03-01
Completion date
2015-01-05
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heathly Volunteers

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.

Interventions

OTHERNo intervention

There is no intervention for this study

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood content differences between the lung disease and healthy control populationsDay 1Test for differences in the blood of individuals with lung disease and normal healthy controls.

Secondary

MeasureTime frameDescription
Genetic expression of relevant genes between the lung disease and healthy control populationsDay 1Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.Day 1Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.
Identify diagnostic and prognostic indicators for lung diseaseDecember 2020Develop and test possible diagnostic and prognostic indicators for various lung diseases.
Develop possible treatment for lung diseaseDecember 2020Develop 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026