Dry Syndrome, Lupus, Rheumatoid Arthritis, Scleroderma, Sjogren Syndrome
Conditions
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.
Interventions
None listed
Sponsors
CHRU de Brest (Brest University Hospital)
University Hospital, Brest
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations | Baseline | The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the proportion of patients with ultrasound abnormalities in each subgroup. | Baseline | Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup. |
| Evaluate the proportion of patients with vascular anomalies in each subgroup | Baseline | Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup |
Countries
France
Contacts
Primary ContactSandrine JOUSSE-JOULIN, Dr
Outcome results
None listed