Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357266
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-07-26
Brief Title:
Differences in Genes and Proteins in Active and Controlled Uveitis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of Differential Gene Expression Profiles in Patients With Defined Ocular Inflammatory Diseases Using CDNA Microarrays and Proteomics
Status:
COMPLETED
Status Verified Date:
2007-10-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients identity
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 patients 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 studys 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 3000-5000 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 proteins 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 eg CD25 as well as responses to antigen and mitogens at the peak and trough serum concentrations of daclizumab therapy
The studys 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 3000-5000 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 proteins 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 eg CD25 as well as responses to antigen and mitogens at the peak and trough serum concentrations of daclizumab therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-EI-0099 | None | None | None |