Overview

This trial is active, not recruiting.

Condition heathly volunteers
Treatment no intervention
Sponsor Clay Marsh MD
Start date March 2011
End date December 2020
Trial size 1500 participants
Trial identifier NCT01386892, 2011H0007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Healthy Volunteer without lung disease
no intervention
There is no intervention for this study

Primary Outcomes

Measure
Blood content differences between the lung disease and healthy control populations
time frame: Day 1

Secondary Outcomes

Measure
Genetic expression of relevant genes between the lung disease and healthy control populations
time frame: Day 1
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
time frame: Day 1
Identify diagnostic and prognostic indicators for lung disease
time frame: December 2020
Develop possible treatment for lung disease
time frame: December 2020

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Immunological Characterization of Blood of Normal Individuals
Principal investigator Clay Marsh, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Ohio State University.