Echo Systemic Sclerosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Sclerosis; Gougerot Sjogren Syndrome; Sicca-Asthenia-Polyalgia Syndrome
• Intervention / Treatment: Other: Ultrasonography

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU Clermont-Ferrand
      • Contact: Marion COUDERC, MD; Phone Number: 04 73 75 14 88; Email: mcouderc@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2017
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Systemic sclerosis; Sicca syndrome; Salivary glands ultrasonography; Gougerot Sjogren syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Sclerosis; Syndrome; Scleroderma, Systemic; Scleroderma, Diffuse; Sjogren's Syndrome; Asthenia
• Other Study ID Numbers: CHU-323; 2016-A01256-45 (OTHER: 2016-A01256-45)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No