Gene ExpressionNCT01052649
Gene Expression Monitoring of Mononuclear Cells (MNC) Subpopulations and Immunological Status and Metabolome Defining of Healthy Population
An observational study of Gene Expression and Metabolomics, run by Blood Transfusion Centre of Slovenia at 1 site in Slovenia.
Trial summary
Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Expression, Metabolomics, Immunological Status
- What is being tested?
- Blood sampling
- How many people
- Not given
- Where
- 1 siteSlovenia
- Study dates
- Aug 2008to not given
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy population
Who may be able to join
- age: 20-70 years
- healthy
Who cannot join
- acute or chronic diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Blood Transfusion Centre of Slovenia
Ljubljana, Ljubljana, 1000
About this study
Official title: Gene Expression Monitoring of Peripheral Blood Mononuclear Cells Subpopulations (CD4+ Cells, CD56+ Cells and CD4+CD25+ Cells) and Immunological Status and Metabolome Defining of Healthy Population
Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and immunological status are defined on same samples.
- Conditions
- Gene Expression, Metabolomics, Immunological Status
- Being tested
- Blood sampling
- Keywords
- MNC subpopulations, Gene Expression, Metabolomics, Immunological Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Other: Blood sampling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene ExpressionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Blood Transfusion Centre of Slovenia
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052649
- Sponsor's protocol ID
- MNC -1-4
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Monitoring of Peripheral Blood Mononuclear Cells Subpopulations (CD4+ Cells, CD56+ Cells and CD4+CD25+ Cells) and Immunological Status and Metabolome Defining of Healthy Population
- ClinicalTrials.gov ID
- NCT01052649
- Acronym / sponsor ID
- MNC -1-4
- Conditions
- Gene Expression, Metabolomics, Immunological Status
- Keywords
- MNC subpopulations, Gene Expression, Metabolomics, Immunological Status
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Blood Transfusion Centre of SloveniaOther government
- Study start
- Aug 2008
- First posted
- 20 Jan 2010 (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.
Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and immunological status are defined on same samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Blood sampling |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy population
Key inclusion criteria (2 listed)
- age: 20-70 years
- healthy
Key exclusion criteria (2 listed)
- acute or chronic diseases
- pregnancy
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 |
|---|---|---|
| Blood sampling | Other | Healthy volunteers |
Primary outcome
Not reported in the source record.
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 20 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gene Expression and Metabolomics, run by Blood Transfusion Centre of Slovenia at 1 site in Slovenia.
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 2 inclusion and 2 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 20 Jan 2010. 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 Slovenia. 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.
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 20 Jan 2010.