Immunological Characterization of Blood of Normal Individuals
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01386892 |
Recruitment Status
:
Active, not recruiting
First Posted
: July 1, 2011
Last Update Posted
: February 11, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Heathly Volunteers | Other: No intervention |
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.
Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Immunological Characterization of Blood of Normal Individuals |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Group/Cohort | Intervention/treatment |
---|---|
Healthy Volunteer
Healthy Volunteer without lung disease
|
Other: No intervention
There is no intervention for this study
|
- Blood content differences between the lung disease and healthy control populations [ Time Frame: Day 1 ]Test for differences in the blood of individuals with lung disease and normal healthy controls.
- Genetic expression of relevant genes between the lung disease and healthy control populations [ Time Frame: Day 1 ]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 ]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 ]Develop and test possible diagnostic and prognostic indicators for various lung diseases.
- Develop possible treatment for lung disease [ Time Frame: December 2020 ]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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386892
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Clay Marsh, M.D. | Ohio State University |
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 |
First Posted: | July 1, 2011 Key Record Dates |
Last Update Posted: | February 11, 2014 |
Last Verified: | February 2014 |