Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sjogren Syndrome, Dry Syndrome, Lupus, Scleroderma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations [Time frame: Baseline]
Secondary outcome measures (2)
- Evaluate the proportion of patients with ultrasound abnormalities in each subgroup. [Time frame: Baseline]
- Evaluate the proportion of patients with vascular anomalies in each subgroup [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- CHU Brest — Brest
Identifiers
NCT: NCT06680310 · 29BRC23.0273 · 2024-A00412-45