CHU Brest
Brest, France
NCT Number: NCT06680310
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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Observational
Brest, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.
Time frame: Baseline
Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup.
Time frame: Baseline
Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
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
Acronym: COUGAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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