Gougerot Sjogren Syndrome, Sicca-Asthenia-Polyalgia Syndrome, Systemic Sclerosis
Conditions
Keywords
Salivary glands ultrasonography, Systemic sclerosis, Gougerot Sjogren syndrome, Sicca syndrome
Brief summary
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
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.
Interventions
OTHERUltrasonography
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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jousse-Joulin ultrasonography score | the day of inclusion | Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated. |
Secondary
| Measure | 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 |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Backup ContactMarion COUDERC, MD
Outcome results
None listed