Sarcoid UveitisLUCSNCT03863782
Lyon Sarcoid Uveitis Cohort
An observational study of Sarcoid Uveitis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoid Uveitis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- Diagnosis of sarcoid uveitis
- First consultation in the department of Internal Medicine at the Croix-Rousse hospital, Lyon, France
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Pascal SEVE contact
Nora Martel contact
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon
Pascal SEVE, pascal.seve@chu-lyon.fr
About this study
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.
- Conditions
- Sarcoid Uveitis
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No specific intervention. Collection of clinical data
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution (persistence or resolution) evaluated by gradation of SEN
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)
Measured: At one year after diagnosis
Secondary outcomes (2)
Anatomic characteristic of sarcoid uveitis
The anatomic characteristics of sarcoid uveitis will be described: anterior or posterior inflammation of greater rings of iris, ciliary margin of iris
Measured: At inclusion visit
Corticoid treatment duration
Treatment used to cure uveitis: duration of corticotherapy treatment
Measured: At one year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoid UveitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863782
- Sponsor's protocol ID
- CRC_GHN_2018_001
- Acronym
- LUCS
- Status last verified
- Apr 2024
- First submitted
- 17 May 2018
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34711577Cotte 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.
PubMed 32917626
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon Sarcoid Uveitis Cohort
- ClinicalTrials.gov ID
- NCT03863782
- Acronym / sponsor ID
- LUCS / CRC_GHN_2018_001
- Conditions
- Sarcoid Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Mar 2019 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoid uveitis | – | Other: No interventionThe cohort is composed by patients diagnosed or treated for sarcoid uveitis in the departement for Internal Medicine, Croix Rousse Hospital, Lyon, France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (2 listed)
- Diagnosis of sarcoid uveitis
- First consultation in the department of Internal Medicine at the Croix-Rousse hospital, Lyon, France
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo specific intervention. Collection of clinical data | Other | Sarcoid uveitis |
Primary outcome
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)
2 secondary outcomes
Anatomic characteristic of sarcoid uveitis
Time frame: At inclusion visit
Corticoid treatment duration
Time frame: At one year after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 34711577Danjou 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.
- Derived from this study: PubMed 32917626Cotte 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.
- Individual participant dataSharing planned: No
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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.
Pascal SEVE contact
Nora Martel contact
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 Sarcoid Uveitis, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal SEVE (pascal.seve@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution (persistence or resolution) evaluated by gradation of SEN (time frame: At one year after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863782, which also lists 2 linked publications.
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 26 Apr 2024.