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Echo Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT03143413
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Systemic Sclerosis Gougerot Sjogren Syndrome Sicca-Asthenia-Polyalgia Syndrome 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
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019


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.





Primary Outcome Measures :
  1. 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.


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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
20 systemic sclerosis, 40 Gougerot-Sjogren syndrome, 40 Sicca-Asthenia-Polyalgia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143413


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Contact: Marion COUDERC, MD 04 73 75 14 88 mcouderc@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Contact: Marion COUDERC, MD    04 73 75 14 88    mcouderc@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03143413     History of Changes
Other Study ID Numbers: CHU-323
2016-A01256-45 ( Other Identifier: 2016-A01256-45 )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Salivary glands ultrasonography
Systemic sclerosis
Gougerot Sjogren syndrome
Sicca syndrome

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Dry Eye Syndromes
Syndrome
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Sjogren's Syndrome
Asthenia
Disease
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms