- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863782
Lyon Sarcoid Uveitis Cohort (LUCS)
Sarcoidosis is a systemic disease with unknown etiology. Chronicity of the disease is observed in 1/3 of cases. Five percent of the affected patients are expected to die due to pulmonary worsening. After pulmonary complications, ocular complications are one of the most frequent complications. In hospital setting 2 to 15% of patients who come for initial uveitis diagnosis are after examination due to Sarcoidosis. Sarcoidosis diagnosis is based on paraclinical exams (biological, radiography) and histological confirmation. Corticotherapy (local or general) is usually used to cure sarcoid uveitis. In case of failure immunosuppressor or anti-tumor necrosis factor (TNF) can be used. In 10% of cases ocular symptoms including blindness are observed. Only treatment administrated quickly after diagnosis of sarcoid uveitis can prevent from ophthalmologic complications.
The main objective of the Lyon Sarcoid Uveitis Cohort study is to analyze the relevance of the paraclinical exam for sarcoid uveitis diagnosis, and to define a better visual and extra-ophthalmologic prognosis and describe the therapeutic practice in our Department.
This study is proposed to all patients diagnosed with Sarcoid uveitis with a histological confirmation and referred to the internal medicine department of the Croix-Rousse hospital, Lyon, France, for etiologic diagnosis or treatment.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pascal SEVE
- Email: pascal.seve@chu-lyon.fr
Study Contact Backup
- Name: Nora Martel
- Email: nora.martel@chu-lyon.fr
Study Locations
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Lyon, France
- Recruiting
- Hospices Civils de Lyon
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Contact:
- Pascal SEVE
- Email: pascal.seve@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
This study is proposed to all patients with a diagnosis of sarcoid uveitis and referred to the Internal Medicine department of the Croix-Rousse hospital
.
Description
Inclusion Criteria:
- Diagnosis of sarcoid uveitis
- First consultation in the department of Internal Medicine at the Croix-Rousse hospital, Lyon, France
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sarcoid uveitis
The cohort is composed by patients diagnosed or treated for sarcoid uveitis in the departement for Internal Medicine, Croix Rousse Hospital, Lyon, France.
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No specific intervention.
Collection of clinical data
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical evolution (persistence or resolution) evaluated by gradation of SEN
Time Frame: At one year after diagnosis
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Persistence of disease is characterized by persistence of intraocular inflammation evaluated by gradation of SEN.
(reference: A Standardization Grading System for Scleritis .
Ophthalmology 2011 Apr;118(4):768-71).
SEN score ranges from 0 to 5 (resolution = score 0 and persistence = score >0)
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At one year after diagnosis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anatomic characteristic of sarcoid uveitis
Time Frame: At inclusion visit
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The anatomic characteristics of sarcoid uveitis will be described: anterior or posterior inflammation of greater rings of iris, ciliary margin of iris
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At inclusion visit
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Corticoid treatment duration
Time Frame: At one year after diagnosis
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Treatment used to cure uveitis: duration of corticotherapy treatment
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At one year after diagnosis
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cotte P, Pradat P, Kodjikian L, Jamilloux Y, Seve P. Diagnostic value of lymphopaenia and elevated serum ACE in patients with uveitis. Br J Ophthalmol. 2021 Oct;105(10):1399-1404. doi: 10.1136/bjophthalmol-2020-316563. Epub 2020 Sep 11.
- Danjou W, Pradat P, Jamilloux Y, Gerfaud-Valentin M, Kodjikian L, Trad S, Seve P. Usefulness of the QuantiFERON test for the diagnosis of tubercular uveitis and the predictions of response to antituberculosis treatment. Br J Ophthalmol. 2023 Apr;107(4):500-504. doi: 10.1136/bjophthalmol-2021-318868. Epub 2021 Oct 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC_GHN_2018_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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