Echo Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03143413
• Other study ID #: CHU-323
• Secondary ID: 2016-A01256-45
• Status: Recruiting
• Start date: March 24, 2017
• Est. completion date: May 2019

Study information

• Verified date: April 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Gougerot Sjogren Syndrome
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Sicca-Asthenia-Polyalgia Syndrome
• Sjogren's Syndrome
• Syndrome
• Systemic Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ultrasonography score equal or higher than 2 on at least one salivary gland		the day of inclusion
Secondary	Ultrasonography score equal or higher than 3 on at least one salivary gland		the day of inclusion
Secondary	Global ultrasonography score higher than 6/16		the day of inclusion
Secondary	Salivary glands area		the day of inclusion