Ocular Inflammatory DiseaseNCT00357266
Differences in Genes and Proteins in Active and Controlled Uveitis
An observational study of Ocular Inflammatory Disease and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will examine blood cells and other tissue samples from people with uveitis (eye inflammation) to try to gain a better understanding of this condition. It will look at 1) the differences in cells when uveitis is active and when it is under control; 2) the genes that control the functions of these cells… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Ocular Inflammatory Disease, Uveitis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2002to 24 Oct 2007
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant is 6 or more years of age.
- Participant has a diagnosis of an ocular inflammatory disease of at least eight weeks' duration prior to enrollment, requiring medical treatment to control the ocular inflammation. This treatment must require using a corticosteroid (e.g., prednisone or equivalent) or an investigational treatment, or any combination of two or more anti-inflammatory treatments, including for example prednisone, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, etc. Participants are anticipated to have, but are not restricted to, the following conditions: scleritis, intermediate or posterior uveitis, intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, Behcet's disease, juvenile rheumatoid arthritis (JRA), retinal vasculitis or sympathetic ophthalmia.
- Participant is currently enrolled in another NEI protocol for one of the above (or related) conditions that requires periodic visits to NIH for treatment and/or evaluation.
- Participant is able to understand and sign an informed consent (or applicable assent) and if the participant is younger than the age 18 at enrollment, has a parent or legal guardian who is able to understand and sign a consent form on their behalf.
Who cannot join
- Participant is under the age of 6 years.
- Participant has inadequate vascular access to obtain a routine venous peripheral whole blood specimen totaling up to 50 mL at a single visit.
- Participants has an inadequate peripheral leukocyte count such that it would be unlikely to provide an adequate RNA sample. For this purpose, a total leukocyte count below 3 x 10(9)/L will exclude a participant at enrollment. Unless there is a recognized medical condition likely to reduce leukocyte counts, blood counts from a prior visit up to 5 weeks earlier may be used to determine eligibility for a first or subsequent sample collection. (A participant who initially enrolls with an adequate leukocyte count may remain enrolled if counts subsequently fall below the limit, but will not have blood samples drawn for this protocol until the leukocyte count recovers above the limit).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Analysis of Differential Gene Expression Profiles in Patients With Defined Ocular Inflammatory Diseases Using CDNA Microarrays and Proteomics
This study will examine blood cells and other tissue samples from people with uveitis (eye inflammation) to try to gain a better understanding of this condition. It will look at 1) the differences in cells when uveitis is active and when it is under control; 2) the genes that control the functions of these cells during different stages of the condition; and 3) the proteins the cells make at these different stages.
Patients 6 years of age or older with an eye inflammation of at least 8 weeks' duration may be eligible for this study. They must currently be enrolled in another NEI protocol for evaluation or treatment of uveitis.
Read more
Participants will provide blood and possibly eye tissue samples as follows:
Blood samples: Blood samples will be drawn, probably from an arm vein, during periods when the inflammation is bad and when it is quiet. No more than 60 mL (about 4 tablespoons) will be drawn at any visit, and no more than eight samples will be collected in 1 year.
Tissue samples: For patients who require eye surgery, a sample of tissue or fluid that is removed as a routine part of surgery may be provided to investigators in this study for research purposes.
Samples will be collected during patients' visits scheduled as part of their other protocol. The samples will be labeled with a special code number to preserve the patient's identity.
Read the detailed description
Ocular inflammatory diseases, including uveitis, cause significant visual loss. Previous non-human investigations have identified several cell types, receptor systems and metabolic intermediates that have led to treatment approaches for human patients. However, information on the human genetic expression of these steps in defined inflammatory disease states is lacking. This non-intervention study proposes to obtain peripheral blood and tissue specimens from patients enrolled in other intramural trials for ocular inflammatory diseases and to apply contemporary cDNA microarray technologies for the analysis of differential gene expression. Test results will not be reported to participants or used for diagnostic or therapeutic purposes.
The study's primary objective is to identify unique gene expression profiles as well as disease relevant genes for patients with ocular inflammatory disease at defined clinical stages using cDNA microarray analysis. This will help provide further insight to understand the pathological mechanisms and potential targets for treatment. Some 3,000-5,000 genes will be examined starting with a selected set associated with interleukin (IL) proteins and their receptors, and with tumor necrosis factors (TNF). Purified peripheral blood mononuclear cells (or whole blood lysates using RNA isolation procedures) will be used to isolate total RNA from these samples. Samples will be taken during periods of active or recurring inflammatory disease and again during periods of quiescence after treatment. The microarray tools and methods for genetic analysis are now available both at NEI and the collaborating NIA laboratories.
A secondary objective is to analyze the circulating protein profiles in serum or other available tissue or fluid specimens from patients with ocular inflammatory disease at the same time points as described above. These samples will be analyzed using 2-dimensional SDS-PAGE for profiling proteomic differences in patients at defined clinical stages. In-gel digestion and subsequent sequence analysis by mass spectroscopy will be performed if differentially expressed protein(s) of interest are to be identified. Other methods such as flow cytometry analysis and proliferation assays using purified PBMCs will be used to examine expression status of cell surface markers of interest (e.g., CD25) as well as responses to antigen and mitogens at the peak and trough serum concentrations of daclizumab therapy.
- Conditions
- Ocular Inflammatory Disease, Uveitis
- Keywords
- Uveitis, Interleukin 2, Interleukin 2 Receptor, Microarrays, Genetic Expression, Daclizumab, HAT, Zenapax, Proteins, RNA, Ocular Inflammatory Disease
- Medical subject headings
- Uveitis, Diabetes Mellitus, Insulin-Dependent, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study start1 Feb 2002
- Study completion24 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Inflammatory DiseaseStudies 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357266
- Sponsor's protocol ID
- 020099
- Other IDs
- 02-EI-0099
- Status last verified
- 24 Oct 2007
- First submitted
- 26 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Schena M, Shalon D, Davis RW, Brown PO. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science. 1995 Oct 20;270(5235):467-70. doi: 10.1126/science.270.5235.467.
PubMed 7569999
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Differential Gene Expression Profiles in Patients With Defined Ocular Inflammatory Diseases Using CDNA Microarrays and Proteomics
- ClinicalTrials.gov ID
- NCT00357266
- Acronym / sponsor ID
- 020099
- Conditions
- Ocular Inflammatory Disease, Uveitis
- Keywords
- Uveitis, Interleukin 2, Interleukin 2 Receptor, Microarrays, Genetic Expression, Daclizumab, HAT, Zenapax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 1 Feb 2002
- Study completion
- 24 Oct 2007
- First posted
- 27 Jul 2006 (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.
This study will examine blood cells and other tissue samples from people with uveitis (eye inflammation) to try to gain a better understanding of this condition. It will look at 1) the differences in cells when uveitis is active and when it is under control; 2) the genes that control the functions of these cells during different stages of the condition; and 3) the proteins the cells make at these different stages.
Patients 6 years of age or older with an eye inflammation of at least 8 weeks' duration may be eligible for this study. They must currently be enrolled in another NEI protocol for evaluation or treatment of uveitis.
Participants will provide blood and possibly eye tissue samples as follows:
Blood samples: Blood samples will be drawn, probably from an arm vein, during periods when the inflammation is bad and when it is quiet. No more than 60 mL (about 4 tablespoons) will be drawn at any visit, and no more than eight samples will be collected in 1 year.
Tissue samples: For patients who require eye surgery, a sample of tissue or fluid that is removed as a routine part of surgery may be provided to investigators in this study for research purposes.
Samples will be collected during patients' visits scheduled as part of their other protocol. The samples will be labeled with a special code number to preserve the patient's identity.
Detailed description
Ocular inflammatory diseases, including uveitis, cause significant visual loss. Previous non-human investigations have identified several cell types, receptor systems and metabolic intermediates that have led to treatment approaches for human patients. However, information on the human genetic expression of these steps in defined inflammatory disease states is lacking. This non-intervention study proposes to obtain peripheral blood and tissue specimens from patients enrolled in other intramural trials for ocular inflammatory diseases and to apply contemporary cDNA microarray technologies for the analysis of differential gene expression. Test results will not be reported to participants or used for diagnostic or therapeutic purposes.
The study's primary objective is to identify unique gene expression profiles as well as disease relevant genes for patients with ocular inflammatory disease at defined clinical stages using cDNA microarray analysis. This will help provide further insight to understand the pathological mechanisms and potential targets for treatment. Some 3,000-5,000 genes will be examined starting with a selected set associated with interleukin (IL) proteins and their receptors, and with tumor necrosis factors (TNF). Purified peripheral blood mononuclear cells (or whole blood lysates using RNA isolation procedures) will be used to isolate total RNA from these samples. Samples will be taken during periods of active or recurring inflammatory disease and again during periods of quiescence after treatment. The microarray tools and methods for genetic analysis are now available both at NEI and the collaborating NIA laboratories.
A secondary objective is to analyze the circulating protein profiles in serum or other available tissue or fluid specimens from patients with ocular inflammatory disease at the same time points as described above. These samples will be analyzed using 2-dimensional SDS-PAGE for profiling proteomic differences in patients at defined clinical stages. In-gel digestion and subsequent sequence analysis by mass spectroscopy will be performed if differentially expressed protein(s) of interest are to be identified. Other methods such as flow cytometry analysis and proliferation assays using purified PBMCs will be used to examine expression status of cell surface markers of interest (e.g., CD25) as well as responses to antigen and mitogens at the peak and trough serum concentrations of daclizumab therapy.
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- Participant is under the age of 6 years.
- Participant has inadequate vascular access to obtain a routine venous peripheral whole blood specimen totaling up to 50 mL at a single visit.
- Participants has an inadequate peripheral leukocyte count such that it would be unlikely to provide an adequate RNA sample. For this purpose, a total leukocyte count below 3 x 10(9)/L will exclude a participant at enrollment. Unless there is a recognized medical condition likely to reduce leukocyte counts, blood counts from a prior visit up to 5 weeks earlier may be used to determine eligibility for a first or subsequent sample collection. (A participant who initially enrolls with an adequate leukocyte count may remain enrolled if counts subsequently fall below the limit, but will not have blood samples drawn for this protocol until the leukocyte count recovers above the limit).
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 2 Jul 2017.
- Background: PubMed 7569999Schena M, Shalon D, Davis RW, Brown PO. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science. 1995 Oct 20;270(5235):467-70. doi: 10.1126/science.270.5235.467.
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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 Ocular Inflammatory Disease and Uveitis, run by National Eye Institute (NEI) 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 4 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 2 Jul 2017. 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?
On the ClinicalTrials.gov record for NCT00357266, which also lists 1 linked publication.
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 2 Jul 2017.