HealthyNCT00926692
Investigations Regarding B-cell Subsets in Humans
An observational study of Healthy, run by Northwell Health at 1 site in United States.
Trial summary
The aim of this research is to define the human equivalent of mouse B1 cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood draw
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2014
- 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: Healthy Control Population
Who may be able to join
- Subject is considered by the physician to be a healthy adult.
Who cannot join
- Subject is under the age of 18
- Subject has an infection or is currently ill
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
The aim of this research is to define the human equivalent of mouse B1 cells.
Read the detailed description
The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.
The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.
- Conditions
- Healthy
- Being tested
- Blood draw
- Keywords
- B-cells, CD5+, B1 Cells, Healthy Controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Subject will have blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | All subjects are considered healthy Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of B-1 cells in humans
an equivalent cell type was isolated in humans
Measured: determined over the years study in effect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Griffin, Northwell Health
- Investigators
- Daniel Griffin, M.D., Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926692
- Sponsor's protocol ID
- GCRC 0266
- Status last verified
- Aug 2015
- First submitted
- 19 Jun 2009
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations Regarding B-cell Subsets in Humans
- ClinicalTrials.gov ID
- NCT00926692
- Acronym / sponsor ID
- GCRC 0266
- Conditions
- Healthy
- Keywords
- B-cells, CD5+, B1 Cells, Healthy Controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jun 2009 (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 aim of this research is to define the human equivalent of mouse B1 cells.
Detailed description
The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.
The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Other: Blood drawAll subjects are considered healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Control Population
Key inclusion criteria (1 listed)
- Subject is considered by the physician to be a healthy adult.
Key exclusion criteria (2 listed)
- Subject is under the age of 18
- Subject has an infection or is currently ill
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 drawSubject will have blood draw. | Other | Healthy Subjects |
Primary outcome
Presence of B-1 cells in humans
Time frame: determined over the years study in effect
an equivalent cell type was isolated in humans
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 26 Aug 2015.
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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.
Daniel Griffin, M.D. principal investigator
Feinstein Institute for Medical Research
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 Healthy, run by Northwell Health 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 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 26 Aug 2015. 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?
Presence of B-1 cells in humans (time frame: determined over the years study in effect). 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 26 Aug 2015.