Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Brest
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
501 Participants
are grouped into 3 trial groupsGroup A: Sjogren syndrome
Group B: Other autoimmune diseases (Lupus/RA/Scleroderma)
Group C: Dry syndrome
Trial outcomes
Primary outcomes
1
Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations
The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.
Time frame
BaselineSecondary outcomes
1
Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.
Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup.
Time frame
Baseline2
Evaluate the proportion of patients with vascular anomalies in each subgroup
Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Brest
Lead sponsor
CHRU de Brest (Brest University Hospital)
Collaborator
Source ClinicalTrials.gov
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