Heathly VolunteersNCT01386892
Immunological Characterization of Blood of Normal Individuals
An observational study of Heathly Volunteers, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heathly Volunteers
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2011to 5 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heathly Volunteers
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention for this study
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Healthy Volunteer without lung disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
Genetic expression of relevant genes between the lung disease and healthy control populations
Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.
Measured: Day 1
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.
Measured: Day 1
Identify diagnostic and prognostic indicators for lung disease
Develop and test possible diagnostic and prognostic indicators for various lung diseases.
Measured: December 2020
Develop possible treatment for lung disease
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.
Measured: December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start1 Mar 2011
- Primary completion5 Jan 2015
- Study completion5 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly VolunteersStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clay Marsh, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386892
- Sponsor's protocol ID
- 2011H0007
- Status last verified
- Nov 2021
- First submitted
- 27 Apr 2011
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Characterization of Blood of Normal Individuals
- ClinicalTrials.gov ID
- NCT01386892
- Acronym / sponsor ID
- 2011H0007
- Conditions
- Heathly Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 5 Jan 2015 (actual)
- Study completion
- 5 Jan 2015 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Other: No interventionHealthy Volunteer without lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention for this study | Other | Healthy Volunteer |
Primary outcome
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.
4 secondary outcomes
Genetic expression of relevant genes between the lung disease and healthy control populations
Time frame: Day 1
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
Time frame: Day 1
Identify diagnostic and prognostic indicators for lung disease
Time frame: December 2020
Develop possible treatment for lung disease
Time frame: December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clay Marsh, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heathly Volunteers, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood content differences between the lung disease and healthy control populations (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.