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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01256-45 | Other Identifier | 2016-A01256-45 |
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Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).
Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.
Descriptive explorative study of three population showing sicca symptoms (Systemic sclerosis, Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome).
Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic sclerosis | Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. |
| |
| Gougerot-Sjogren syndrome | Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). |
| |
| Sicca-Asthenia-Polyalgia syndrome | It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Other | Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France). Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated. |
| Measure | Description | Time Frame |
|---|---|---|
| Jousse-Joulin ultrasonography score | Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated. | the day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonography score equal or higher than 2 on at least one salivary gland | the day of inclusion | |
| Ultrasonography score equal or higher than 3 on at least one salivary gland | the day of inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr | |
| Marion COUDERC, MD | Contact | 04 73 75 14 88 | mcouderc@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | Auvergne | 63003 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001172 | Arthritis, Rheumatoid |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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|
| Global ultrasonography score higher than 6/16 | the day of inclusion |
| Salivary glands area | the day of inclusion |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D055585 |
| Physical Phenomena |