Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

Not yet recruiting

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

• Registration Number: NCT06680310
• Lead Sponsor: University Hospital, Brest

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 501

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations	Baseline	The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.

Secondary Outcome Measures

Name	Time	Method
Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.	Baseline	Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup.
Evaluate the proportion of patients with vascular anomalies in each subgroup	Baseline	Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup

Trial Locations

Locations (1)

CHU Brest; 🇫🇷 Brest, France