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

University Hospital, Brest1,000 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,000

Conditions

Sjogren's Syndrome

Interventions

Blood, fluid, sells and urine samplesOTHER

Blood, fluid, sells and urine samples will be collected.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU de Brest

Brest, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Inclusion

Secondary Outcomes

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

Time frame: 10 years

Number of patients with rheumatological manifestations

number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease

Time frame: 10 years

Number of patients with dermatological manifestations

number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease

Time frame: 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....

Time frame: 10 years

Disease evolution criteria

modification of the ESSDAI at each visit

Time frame: 10 years

Central Contacts

Valérie Devauchelle, MD,PhD

CONTACT

33 (0) 2 98 34 72 64 valerie.devauchelle-pensec@chu-brest.fr

Data from ClinicalTrials.gov

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