Sjogren's Syndrome
Conditions
Brief summary
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
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.
Interventions
OTHERBlood, fluid, sells and urine samples
Blood, fluid, sells and urine samples will be collected.
Sponsors
University Hospital, Brest
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
* Sjögren patients * Non-Sjögren controls (retrospective)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria) | Inclusion | Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure | 10 years | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease |
| Number of patients with rheumatological manifestations | 10 years | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease |
| Number of patients with dermatological manifestations | 10 years | number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease |
| Description diagnostic performance of new tests | 10 years | 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.... |
| Disease evolution criteria | 10 years | modification of the ESSDAI at each visit |
Countries
France
Contacts
CONTACTValérie Devauchelle, MD,PhD
PRINCIPAL_INVESTIGATORValérie Devauchelle
CHRU BREST
Outcome results
None listed