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Completed

NCT Number: NCT01386892

Immunological Characterization of Blood of Normal Individuals

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.

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Key information

Conditions

Heathly Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

There is no intervention for this study

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2011
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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