Prospective Multicenter Study of Ultrasound Evaluation of Salivary Glands in Patients with Sjögren's Disease Compared with Patients with Connective Tissue Diseases (lupus, Scleroderma, Rheumatoid Arthritis) and Healthy Subjects with Dry Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations
研究概览
简要总结
Prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with Sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (RA), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).
详细描述
This is a non-interventional study involving patients who are routinely monitored for their disease, and who typically benefit from ultrasound of the parotid and submandibular salivary glands as part of their dry mouth syndrome. Recruitment will be facilitated by the fact that these will be "general population" patients with Sjögren's disease, lupus, RA, scleroderma with dry syndrome, and control patient.
The study will be conducted over a single visit, including a clinical examination and an ultrasound scan. Ultrasound will not be blinded to the clinic, so we will need only one examiner per center.
This is a study in routine care, with no additional costs and no expected constraints. The examination will be carried out as part of their routine follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients
- •Patients fulfilling Sjogren criteria (2012 and 2016 American-European criteria) or Lupus according to ACR 2019 criteria or RA according to ACR/EULAR 2010 criteria or scleroderma according to ACR-EULAR 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease).
排除标准
- •Uncooperative patient who has refused to participate in the study.
- •Patients unable to understand the protocol, under guardianship or curatorship.
- •Patients not affiliated to the French Social Security system.
结局指标
主要结局
Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations
时间窗: Baseline
The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.
次要结局
- Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.(Baseline)
- Evaluate the proportion of patients with vascular anomalies in each subgroup(Baseline)