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Immunological Characterization of Blood of Normal Individuals

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ClinicalTrials.gov Identifier: NCT01386892
Recruitment Status : Active, not recruiting
First Posted : July 1, 2011
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Clay Marsh MD, The Ohio State University

Study Description
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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.

Condition or disease Intervention/treatment
Heathly Volunteers Other: No intervention

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.


Study Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy Volunteer
Healthy Volunteer without lung disease
 Other: No intervention
There is no intervention for this study


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Identify diagnostic and prognostic indicators for lung disease [ Time Frame: December 2020 ]
    Develop and test possible diagnostic and prognostic indicators for various lung diseases.

  4. 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
Blood Saliva Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014