Echo Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome

Conditions
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Systemic Sclerosis, Gougerot Sjogren Syndrome, Sicca-Asthenia-Polyalgia Syndrome

Intervention / Treatment
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* Other: Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemic sclerosis diagnosis established by a rheumatologist and met ACR 2012 criteria Or primary Gougerot-Sjogren patient who met American-European Consensus Group (AECG) classification criteria. Or patient presenting a sicca syndrome but not met Gougerot-Sjogren criteria Exclusion Criteria: History of radiotherapy on face and neck Infection such as VIH or Hepatitis C Sarcoidosis Amylosis Wearing contact lenses Hyper IgG4 syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic sclerosis<br>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. | Other: Ultrasonography<br>* 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.<br>|
| Gougerot-Sjogren syndrome<br>Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). | Other: Ultrasonography<br>* 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.<br>|
| Sicca-Asthenia-Polyalgia syndrome<br>It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). | Other: Ultrasonography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Global ultrasonography score higher than 6/16 |  | the day of inclusion | 
| Salivary glands area |  | the day of inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salivary glands ultrasonography, Systemic sclerosis, Gougerot Sjogren syndrome, Sicca syndrome