Immunological Characterization of Blood of Normal Individuals

NCT01386892 | Completed

• 1 other identifier: 2011H0007
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heathly Volunteers

Outcome Measures

Primary Outcomes (1)

• Blood content differences between the lung disease and healthy control populations

  Test for differences in the blood of individuals with lung disease and normal healthy controls.

  Day 1

Secondary Outcomes (4)

• Genetic expression of relevant genes between the lung disease and healthy control populations

  Day 1

• Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.

  Day 1

• Identify diagnostic and prognostic indicators for lung disease

  December 2020

• Develop possible treatment for lung disease

  December 2020

Study Arms (1)

Healthy Volunteer

Healthy Volunteer without lung disease

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Saliva Urine

Study Officials

• Clay Marsh, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: July 1, 2011
• Study Start: March 1, 2011
• Primary Completion: January 5, 2015
• Study Completion: January 5, 2015
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

US (1)