B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal to participate
- •Pregnant and lactating woman
研究组 & 干预措施
Non-Sjögren witnesses
patients diagnosed no Sjögren
干预措施: Blood, fluid, sells and urine samples (Other)
Sjögren patients
patients diagnosed Sjögren
干预措施: Blood, fluid, sells and urine samples (Other)
结局指标
主要结局
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
时间窗: Inclusion
Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.
次要结局
- 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 with rheumatological manifestations(10 years)
- Number of patients with dermatological manifestations(10 years)
- Disease evolution criteria(10 years)
- Description diagnostic performance of new tests(10 years)