UveitisNCT00874471
Uveitis Gene-Expression Profiling
An observational study of Uveitis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Uveitis is a group of troublesome diseases that collectively represent a cause of blindness comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jul 2010
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals suffering from selected subtypes of uveitis, individuals suffering from selected autoimmune disease and healthy individuals.
Who may be able to join
- The study group will include patients aged 21 years or older attending the Uveitis Clinic at the Casey Eye Institute at OHSU who have uveitis of the following subtypes:
- ankylosing spondylitis
- sarcoidosis
- Behçet's disease
- toxoplasmosis
- herpetic acute retinal necrosis; AND
Show all 12Show fewer
- idiopathic uveitis
- Another group of patients, also aged 21 years or more, with the following diseases but no uveitis, will be recruited from the Rheumatology Clinic at OHSU as follows:
- ankylosing spondylitis
- sarcoidosis; AND
- Behçet's disease
- The study group will also include 30 normal control volunteers aged 21 years or older.
Who cannot join
- Special/vulnerable subject populations (e.g., mentally impaired persons and children) will not be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239-3098
About this study
Uveitis is a group of troublesome diseases that collectively represent a cause of blindness comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. The investigators propose to create a data base on peripheral blood gene expression for patients with 3 of the most important diseases associated with uveitis: ankylosing spondylitis, sarcoidosis, and Behcet's disease. The investigators will quantitatively measure the expression of consistent alteration in peripheral blood from patients with more than 40,000 gene sequences using microarray gene chip technology. This approach is known to detect systemic immune-mediated disease. The investigators will use this data base to:
- Determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behcet's can be distinguished from a normal population or controls with the same systemic disease but no history of uveitis
- Determine if the profile of gene expression can distinguish infectious or idiopathic forms of uveitis from patients with spondylitis, sarcoidosis, or Behcet's
- Determine how this gene profile changes over time as episodic disease such as spondylitis or Behcet's activates or remits
- Correlate the changes in gene expression with the prognosis of the ocular inflammatory process.
The creation of a gene expression data base for patients with uveitis has the potential to clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for predicting prognosis.
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sarcoidosis | Not described | |
| ankylosing spondylitis | Not described | |
| Behcet's disease | Not described | |
| toxoplasmosis | Not described | |
| herpetic acute retinal necrosis | Not described | |
| idiopathic uveitis | Not described | |
| ankylosing spondylitis (no uveitis) | Not described | |
| sarcoidosis (no uveitis) | Not described | |
| Behcet's disease (no uveitis) | Not described | |
| normal control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of blood transcriptome with form of uveitis
Measured: time of office visit for disease evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJun 2005
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jim Rosenbaum, Oregon Health and Science University
- Investigators
- James Rosenbaum, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874471
- Sponsor's protocol ID
- R01EY015858
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2009
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uveitis Gene-Expression Profiling
- ClinicalTrials.gov ID
- NCT00874471
- Acronym / sponsor ID
- R01EY015858
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jul 2010 (actual)
- First posted
- 2 Apr 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.
Uveitis is a group of troublesome diseases that collectively represent a cause of blindness comparable to diabetes. Most forms of uveitis are either infectious or immune-mediated. The investigators propose to create a data base on peripheral blood gene expression for patients with 3 of the most important diseases associated with uveitis: ankylosing spondylitis, sarcoidosis, and Behcet's disease. The investigators will quantitatively measure the expression of consistent alteration in peripheral blood from patients with more than 40,000 gene sequences using microarray gene chip technology. This approach is known to detect systemic immune-mediated disease. The investigators will use this data base to:
- Determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or Behcet's can be distinguished from a normal population or controls with the same systemic disease but no history of uveitis
- Determine if the profile of gene expression can distinguish infectious or idiopathic forms of uveitis from patients with spondylitis, sarcoidosis, or Behcet's
- Determine how this gene profile changes over time as episodic disease such as spondylitis or Behcet's activates or remits
- Correlate the changes in gene expression with the prognosis of the ocular inflammatory process.
The creation of a gene expression data base for patients with uveitis has the potential to clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for predicting prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| sarcoidosis | – | – |
| ankylosing spondylitis | – | – |
| Behcet's disease | – | – |
| toxoplasmosis | – | – |
| herpetic acute retinal necrosis | – | – |
| idiopathic uveitis | – | – |
| ankylosing spondylitis (no uveitis) | – | – |
| sarcoidosis (no uveitis) | – | – |
| Behcet's disease (no uveitis) | – | – |
| normal control | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals suffering from selected subtypes of uveitis, individuals suffering from selected autoimmune disease and healthy individuals.
Key inclusion criteria (12 listed)
- The study group will include patients aged 21 years or older attending the Uveitis Clinic at the Casey Eye Institute at OHSU who have uveitis of the following subtypes:
- Another group of patients, also aged 21 years or more, with the following diseases but no uveitis, will be recruited from the Rheumatology Clinic at OHSU as follows:
- The study group will also include 30 normal control volunteers aged 21 years or older.
Key exclusion criteria (1 listed)
- Special/vulnerable subject populations (e.g., mentally impaired persons and children) will not be enrolled.
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
Correlation of blood transcriptome with form of uveitis
Time frame: time of office visit for disease evaluation
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 9 Apr 2014.
Related trials for Uveitis
Not yet recruitingObservational study
The Microbiome in Uveitis and Pediatric Inflammatory Diseases
Noninfectious Uveitis
RecruitingObservational study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Presumed Trematode Induced Uveitis, Uveitis
RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Active Non-anterior, Non-infectious Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
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.
James Rosenbaum, MD principal investigator
Oregon Health and Science University
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 Uveitis, run by Oregon Health and Science University 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 12 inclusion and 1 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 9 Apr 2014. 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?
Correlation of blood transcriptome with form of uveitis (time frame: time of office visit for disease evaluation). 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 9 Apr 2014.