NCT06680310

Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 501 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Sjogren Syndrome
• Dry Syndrome
• Lupus
• Scleroderma
• Rheumatoid Arthritis

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: France