B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

Study Overview
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Brief Summary
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The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

Detailed Description
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The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology. Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y. Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.

Official Title
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B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Other: Blood, fluid, sells and urine samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...) Patient affiliated with Social Security Patient who has signed written informed consent Exclusion Criteria: Refusal to participate Pregnant and lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sjögren patients Non-Sjögren controls (retrospective)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sjögren patients<br>patients diagnosed Sjögren | Other: Blood, fluid, sells and urine samples<br>* Blood, fluid, sells and urine samples will be collected.<br>|
| Other: Non-Sjögren witnesses<br>patients diagnosed no Sjögren | Other: Blood, fluid, sells and urine samples<br>* Blood, fluid, sells and urine samples will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria) | Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment. | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease | 10 years | 
| Number of patients with rheumatological manifestations | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease | 10 years | 
| Number of patients with dermatological manifestations | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease | 10 years | 
| Description diagnostic performance of new tests | after evaluation of all différents test performed added to the classical items of the ACR 2017: ie ultrasound parenchymal abnormalities, sub population of B cells.... | 10 years | 
| Disease evolution criteria | modification of the ESSDAI at each visit | 10 years |