B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood, fluid, sells and urine samples.
- Who it may be relevant to
- Registry conditions: Sjogren's Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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
- Other Blood, fluid, sells and urine samples
Blood, fluid, sells and urine samples will be collected.
Primary outcome measures
- Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria) [Time frame: Inclusion]
Secondary outcome measures (5)
- Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure [Time frame: 10 years]
- Number of patients with rheumatological manifestations [Time frame: 10 years]
- Number of patients with dermatological manifestations [Time frame: 10 years]
- Description diagnostic performance of new tests [Time frame: 10 years]
- Disease evolution criteria [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU de Brest — Brest
Identifiers
NCT: NCT04931160 · 29BRC19.0091