Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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).

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Detailed Description

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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

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Sjogren Syndrome Dry Syndrome Lupus Scleroderma Rheumatoid Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Sjogren syndrome

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

No interventions assigned to this group

Other autoimmune diseases (Lupus/RA/Scleroderma)

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

No interventions assigned to this group

Dry syndrome

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

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No