Echo Systemic Sclerosis

NCT ID: NCT03143413

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-24

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Systemic Sclerosis Gougerot Sjogren Syndrome Sicca-Asthenia-Polyalgia Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasonography

Intervention Type OTHER

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).

Ultrasonography

Intervention Type OTHER

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).

Ultrasonography

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Marion COUDERC, MD

Role: CONTACT

04 73 75 14 88

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Marion COUDERC, MD

Role: backup

04 73 75 14 88

Other Identifiers

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2016-A01256-45

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-323

Identifier Type: -

Identifier Source: org_study_id

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