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Lyon Sarcoid Uveitis Cohort (LUCS)

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ClinicalTrials.gov Identifier: NCT03863782
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Sarcoid Uveitis Other: No intervention

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lyon Sarcoid Uveitis Cohort
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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.
Other: No intervention
No specific intervention. Collection of clinical data




Primary Outcome Measures :
  1. Clinical evolution (persistence or resolution) evaluated by gradation of SEN [ Time Frame: At one year after diagnosis ]
    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)


Secondary Outcome Measures :
  1. Anatomic characteristic of sarcoid uveitis [ Time Frame: At inclusion visit ]
    The anatomic characteristics of sarcoid uveitis will be described: anterior or posterior inflammation of greater rings of iris, ciliary margin of iris

  2. Corticoid treatment duration [ Time Frame: At one year after diagnosis ]
    Treatment used to cure uveitis: duration of corticotherapy treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

.

Criteria

Inclusion Criteria:

  • Diagnosis of sarcoid uveitis
  • First consultation in the department of Internal Medicine at the Croix-Rousse hospital, Lyon, France

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863782


Contacts
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Contact: Pascal SEVE pascal.seve@chu-lyon.fr
Contact: Nora Martel nora.martel@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Pascal SEVE       pascal.seve@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03863782    
Other Study ID Numbers: CRC_GHN_2018_001
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Sarcoidosis
Uveal Diseases
Eye Diseases
Lymphoproliferative Disorders
Lymphatic Diseases