Immunological Characterization of Blood of Normal Individuals - Full Text View

Purpose

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.

Condition	Intervention
Heathly Volunteers	Other: No intervention


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Immunological Characterization of Blood of Normal Individuals

Resource links provided by NLM:

MedlinePlus related topics: Lung Diseases

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

Blood content differences between the lung disease and healthy control populations [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Test for differences in the blood of individuals with lung disease and normal healthy controls.

Secondary Outcome Measures:

Genetic expression of relevant genes between the lung disease and healthy control populations [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Test 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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Analyze 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 disease [ Time Frame: December 2020 ] [ Designated as safety issue: No ]
Develop and test possible diagnostic and prognostic indicators for various lung diseases.
Develop possible treatment for lung disease [ Time Frame: December 2020 ] [ Designated as safety issue: No ]
Develop 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.

Biospecimen Retention: Samples With DNA

Blood Saliva Urine


Estimated Enrollment:	1500
Study Start Date:	March 2011
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Healthy Volunteer Healthy Volunteer without lung disease	Other: No intervention There is no intervention for this study

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386892

Locations


United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Clay Marsh MD

Investigators


Principal Investigator:	Clay Marsh, M.D.	Ohio State University

More Information


Responsible Party:	Clay Marsh MD, SR Assoc VP for Health Sciences Research, Vice Dean of Research for the College of Medicine, Executive Director of the Center for Personalized Health Care, Director of the Center for Critical and Respiratory Care, The Ohio State University
ClinicalTrials.gov Identifier:	NCT01386892 History of Changes
Other Study ID Numbers:	2011H0007
Study First Received:	April 27, 2011
Last Updated:	February 10, 2014
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 28, 2016