Clinical trial NCT06680310: Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sjogren Syndrome
Dry Syndrome
Lupus
Scleroderma
Rheumatoid Arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: CHRU de Brest (Brest University Hospital)
First posted: 2024-11-08
Enrollment: 501
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Sjögren's disease, all patients with autoimmune diseases such as LUPUS, scleroderma or rheumatoid arthritis with dry syndrome, and a population of healthy controls with dry syndrome and no autoimmune disease as mentioned above.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations
timeFrame: Baseline
Secondary outcomes:
measure: Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.
timeFrame: Baseline
measure: Evaluate the proportion of patients with vascular anomalies in each subgroup
timeFrame: Baseline
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References: