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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00412-45 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| CHRU de Brest (Brest University Hospital) | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sjogren syndrome | Ultrasound of the parotid and submandibular salivary glands in routine care of patients with Sjögren | ||
| 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) | ||
| Dry syndrome | Ultrasound of the parotid and submandibular salivary glands in routine care of patients with dry syndrome |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Evaluate the proportion of patients with vascular anomalies in each subgroup |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine JOUSSE-JOULIN, Dr | Contact | 02 98 34 72 68 | sandrine.jousse-joulin@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D045743 | Scleroderma, Diffuse |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup |
| Baseline |
| D014987 |
| Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012595 | Scleroderma, Systemic |
| D012871 | Skin Diseases |