Clinical trial NCT03143413: Echo Systemic Sclerosis
Official title: Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Gougerot Sjogren Syndrome
Sicca-Asthenia-Polyalgia Syndrome
Keywords: Salivary glands ultrasonography
Systemic sclerosis
Gougerot Sjogren syndrome
Sicca syndrome
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Jousse-Joulin ultrasonography score
timeFrame: the day of inclusion
Secondary outcomes:
measure: Ultrasonography score equal or higher than 2 on at least one salivary gland
timeFrame: the day of inclusion
measure: Ultrasonography score equal or higher than 3 on at least one salivary gland
timeFrame: the day of inclusion
measure: Global ultrasonography score higher than 6/16
timeFrame: the day of inclusion
measure: Salivary glands area
timeFrame: the day of inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Auvergne
Study officials:
References: