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NCT00116090 · ClinicalTrials.gov registry record
Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study
A clinical trial of Cancer and Infection, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 6,300
- Enrollment target
- 4
- Study locations
NCT00116090: Completed study of Cancer and Infection, sponsored by National Eye Institute (NEI).
NCT00116090 is a study of Cancer and Infection that has completed, run by National Eye Institute (NEI). The registered enrollment target is 6,300 participants, above the 3,481-participant average among 615 other Cancer trials with a reported enrollment target (81% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116090, a study of Cancer and Infection, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 6,300 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is not enough to control the diseases. Researchers expect to gain information about whether immunosuppressive therapy is suitable for patients and which substances should be avoided. Also, the study will evaluate the frequency of short-term complications with immunosuppressive therapy as well as benefits that the therapy can bring to treatment of eye diseases. The medical charts of patients up to age 65 (median age range of 21 to 65) who have had an inflammatory, noninfectious eye disease may be examined for this study. A database will be constructed through a chart review of patients seen in the uveitis clinic of the National Eye Institute since 1977 and three other sites. Patients who are considered exposed to immunosuppressive therapies will be compared with two groups: the general U.S. population and an internal group of patients with the same inflammatory eye diseases who did not receive immunosuppression. Data regarding about 10,000 to 15,000 patients will be collected. Patients will not be identified by the chart reviews. The incidence of cancer will be examined as well as the outcomes of immosuppressive therapy as measured by control of the eye disease, visual sharpness, changes in the use of corticosteroids, and rates of remission-when disease symptoms are lessened. Also examined will be medical charts of a control group of patients who did not receive immunosuppressive therapy for their uveitis. Data on cancer incidence would be more difficult to obtain, requiring personal contact with patients. In such situations, patients will be contacted by phone or mail, and those providing informed consent will be a
Conditions Studied
Study Locations (4)
Maryland
- Johns Hopkins University - Baltimore
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Oregon
- Oregon Health Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,300 participants |
| Start Date | 2005-06-16 |
| Est. Completion | 2008-04-21 |
What the finished NCT00116090 record still lists
NCT00116090 is an observational study that tracks outcomes without assigning an intervention. Its 6,300 participants enrollment target places it among the larger protocols in the corpus, above the 3,481-participant average among 615 other Cancer trials with a reported enrollment target (81% higher).
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT00116090 reports a single indexed study location in Maryland, Massachusetts, Oregon.
Frequently Asked Questions
What is clinical trial NCT00116090 about?
NCT00116090 is a clinical study titled "Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study". This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding dise...
What is the current status of trial NCT00116090?
This trial is currently completed. The enrollment target is 6,300 participants. The study started on 2005-06-16. Estimated completion is 2008-04-21.
What conditions does trial NCT00116090 study?
This clinical trial studies the following conditions: Cancer, Infection, Uveitis, Immunosuppression, Mortality.
Who is sponsoring clinical trial NCT00116090?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00116090 being conducted?
This trial has 4 study locations across Maryland, Massachusetts, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00116090's enrollment target sits among peer trials
6,300 39th of 615 higher than 577 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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