B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome (BRAISES-DiaPSS)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Sjogren's Syndrome

Treatments: Other: Blood, fluid, sells and urine samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04931160

BRAISE DiaPSS

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Sjögren patients

Active Comparator group

Description:

patients diagnosed Sjögren

Treatment:

Other: Blood, fluid, sells and urine samples

Non-Sjögren witnesses

Other group

Description:

patients diagnosed no Sjögren

Treatment:

Other: Blood, fluid, sells and urine samples