Normal Immune Cell FunctionNCT01882582
Evaluation of Immune Signaling Networks in Healthy Human Volunteers
An observational study of Normal Immune Cell Function, run by Martin Angst at 1 site in United States.
Trial summary
The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Immune Cell Function
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2013
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study population consists of a community sample.
Who may be able to join
- Age 18-50
- Good general health
Who cannot join
- Recent cold or flu
- Chronic use of medications affecting the immune system
- Chronic illness
- Smoking habit
- History of drug abuse
- Current recreational drug use
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Results of this study will provide the foundation for helping us evaluate changes in immune cell activities in response to surgery and drugs used in anesthesia. The overall purpose of our research is to understand immune health in the context of anesthesia and surgery.
- Conditions
- Normal Immune Cell Function
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical and functional changes of circulating immune cells over time in healthy individuals
This is an exploratory study. Numerical and functional (phosphorylation of signaling molecules and transcription factors) behavior of all circulating immune cells will be captured. Blood specimens collected at referenced time points will be analyzed with mass cytometry.
Measured: Day 1, Day 2, Day 7, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Immune Cell FunctionStudies 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
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Angst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Angst, Stanford University
- Investigators
- Martin S Angst, MD, Principal investigator, Stanford University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882582
- Sponsor's protocol ID
- 25292
- Status last verified
- May 2016
- First submitted
- 18 Jun 2013
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Signaling Networks in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT01882582
- Acronym / sponsor ID
- 25292
- Conditions
- Normal Immune Cell Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Martin AngstUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jun 2013 (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.
The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Results of this study will provide the foundation for helping us evaluate changes in immune cell activities in response to surgery and drugs used in anesthesia. The overall purpose of our research is to understand immune health in the context of anesthesia and surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population consists of a community sample.
Key inclusion criteria (2 listed)
- Age 18-50
- Good general health
Key exclusion criteria (6 listed)
- Recent cold or flu
- Chronic use of medications affecting the immune system
- Chronic illness
- Smoking habit
- History of drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical and functional changes of circulating immune cells over time in healthy individuals
Time frame: Day 1, Day 2, Day 7, Day 28
This is an exploratory study. Numerical and functional (phosphorylation of signaling molecules and transcription factors) behavior of all circulating immune cells will be captured. Blood specimens collected at referenced time points will be analyzed with mass cytometry.
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 4 May 2016.
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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.
Martin S Angst, MD principal investigator
Stanford University SOM
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 Normal Immune Cell Function, run by Martin Angst 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 2 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 4 May 2016. 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?
Numerical and functional changes of circulating immune cells over time in healthy individuals (time frame: Day 1, Day 2, Day 7, Day 28). 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 4 May 2016.