NCT03143413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

May 4, 2017

Last Update Submit

April 30, 2018

Conditions

Systemic SclerosisGougerot Sjogren SyndromeSicca-Asthenia-Polyalgia Syndrome

Keywords

Salivary glands ultrasonographySystemic sclerosisGougerot Sjogren syndromeSicca syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

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

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

Sicca-Asthenia-Polyalgia syndrome

It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other).

Other: Ultrasonography

Interventions

UltrasonographyOTHER

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 syndromeSicca-Asthenia-Polyalgia syndromeSystemic sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • History of radiotherapy on face and neck
  • Infection such as VIH or Hepatitis C
  • Sarcoidosis
  • Amylosis
  • Wearing contact lenses
  • Hyper IgG4 syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, SystemicSjogren's Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Marion COUDERC, MD

CONTACT

04 73 75 14 88mcouderc@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

March 24, 2017

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

FR(1)