Echo Systemic Sclerosis

• Conditions: Sicca-Asthenia-Polyalgia Syndrome; Systemic Sclerosis; Gougerot Sjogren Syndrome
• Interventions: Other: Ultrasonography

• Registration Number: NCT03143413
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2017-03-24
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01
• Primary Completion: 2019-03
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gougerot-Sjogren syndrome	Ultrasonography	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	Ultrasonography	It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other).
Systemic sclerosis	Ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Salivary glands area	the day of inclusion
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France