Clinical Trial: Echo Systemic Sclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Jousse-Joulin ultrasonography score [ Time Frame: the day of inclusion ]

Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ultrasonography score equal or higher than 2 on at least one salivary gland [ Time Frame: the day of inclusion ]
  • Ultrasonography score equal or higher than 3 on at least one salivary gland [ Time Frame: the day of inclusion ]
  • Global ultrasonography score higher than 6/16 [ Time Frame: the day of inclusion ]
  • Salivary glands area [ Time Frame: the day of inclusion ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: May 4, 2017
Date Started: March 24, 2017
Date Completion: May 2019
Last Updated: May 4, 2017
Last Verified: May 2017