Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Dry Syndrome; Sjogren Syndrome; Scleroderma; Lupus; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT06680310

2024-A00412-45 (Other Identifier)

29BRC23.0273

Details and patient eligibility

About

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).

Full 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.

Enrollment: 501 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

501 participants in 3 patient groups

Sjogren syndrome

Description:

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with Sjögren

Other autoimmune diseases (Lupus/RA/Scleroderma)

Description:

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with other autoimmune diseases (Lupus/RA/Scleroderma)

Dry syndrome

Description:

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with dry syndrome