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

Not Applicable

Recruiting

• Conditions: Sjogren's Syndrome
• Interventions: Other: Blood, fluid, sells and urine samples

• Registration Number: NCT04931160
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study Start: 2020-02-10
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2035-02-10
• Study Completion: 2035-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sjögren patients	Blood, fluid, sells and urine samples	patients diagnosed Sjögren
Non-Sjögren witnesses	Blood, fluid, sells and urine samples	patients diagnosed no Sjögren

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Disease evolution criteria	10 years	modification of the ESSDAI at each visit
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....

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France