Systemic Lupus ErythematosusNCT01230112
The Role of ITGAM in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Northwell Health at 1 site in United States.
Trial summary
Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2012
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype Registry
Who may be able to join
- males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health
- Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample
Who cannot join
- History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease
- History of cancer or lymphoma
- Current use of aspirin, prednisone, or NSAID or any immunosuppressant
- Self reported HIV
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: TAP0307.6: Sub-study of TAP 0307- Enrollment of Normal Controls to Study the Role of ITGAM in Systemic Lupus Erythematosus
Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230112
- Sponsor's protocol ID
- 09-289
- Status last verified
- Jul 2013
- First submitted
- 27 Oct 2010
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP0307.6: Sub-study of TAP 0307- Enrollment of Normal Controls to Study the Role of ITGAM in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01230112
- Acronym / sponsor ID
- 09-289
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Oct 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 to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype Registry
Key inclusion criteria (2 listed)
- males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health
- Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample
Key exclusion criteria (4 listed)
- History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease
- History of cancer or lymphoma
- Current use of aspirin, prednisone, or NSAID or any immunosuppressant
- Self reported HIV
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
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 30 Jul 2013.
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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 Systemic Lupus Erythematosus, 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 2 inclusion and 4 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 30 Jul 2013. 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.
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 30 Jul 2013.