Inflammation, BrainNCT03027232
Control of Leukocyte Function
An observational study of Inflammation, Brain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Brain
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 15 Dec 2017
- 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: Normal healthy volunteers
Who may be able to join
- any healthy volunteer
Who cannot join
- pregnancy
- needing/using drugs
- inflammatory or infectious complications
Trial locations and contacts
1 site in 1 country.
About this study
The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.
Read the detailed description
The proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. Many aspects of immune cell regulation are unknown. A better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases.
The investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving ATP release and purinergic receptors. The purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.
- Conditions
- Inflammation, Brain
- Being tested
- No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies
- Keywords
- infection
- Medical subject headings
- Encephalitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (drugs) will be given. Purpose: collecting blood for in vitro studiesOther
No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.
The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.
Measured: Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2007
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation, BrainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Junger, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027232
- Sponsor's protocol ID
- 2007P000215
- Status last verified
- Apr 2018
- First submitted
- 13 Jan 2017
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Leukocyte Function
- ClinicalTrials.gov ID
- NCT03027232
- Acronym / sponsor ID
- 2007P000215
- Conditions
- Inflammation, Brain
- Keywords
- infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 Jan 2017 (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 protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.
Detailed description
The proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. Many aspects of immune cell regulation are unknown. A better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases.
The investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving ATP release and purinergic receptors. The purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal healthy volunteers
Key inclusion criteria (1 listed)
- any healthy volunteer
Key exclusion criteria (3 listed)
- pregnancy
- needing/using drugs
- inflammatory or infectious complications
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 intervention (drugs) will be given. Purpose: collecting blood for in vitro studiesNo drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept. | Other | – |
Primary outcome
Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.
Time frame: Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.
The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.
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 27 Apr 2018.
- Individual participant dataSharing planned: No
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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 Inflammation, Brain, run by Beth Israel Deaconess Medical Center 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 1 inclusion and 3 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 27 Apr 2018. 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?
Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling. (time frame: Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.). 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 27 Apr 2018.