Echo Systemic Sclerosis

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Sicca-Asthenia-Polyalgia Syndrome; Systemic Sclerosis; Gougerot Sjogren Syndrome

Treatments: Other: Ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT03143413

2016-A01256-45 (Other Identifier)

CHU-323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Systemic sclerosis

Description:

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.

Treatment:

Other: Ultrasonography

Gougerot-Sjogren syndrome

Description:

Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia).

Treatment:

Other: Ultrasonography

Sicca-Asthenia-Polyalgia syndrome

Description:

It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other).

Treatment:

Other: Ultrasonography