Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease (MASAÏ)

Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome

Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma.

The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.

Study Overview

• Status: Unknown
• Conditions: Primary sjögren's Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 242

Contacts and Locations

• Study Contact: Name: Valerie DEVAUCHELLE; Phone Number: 2 98 34 72 64; Email: valerie.devauchelle-pensec@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
  • Lille, France, 59037
    • Not yet recruiting
    • CHU de Lille
  • Montpellier, France, 34295
    • Not yet recruiting
    • CHU de MONTEPELLIER
    • Contact: Jacques MOREL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Primary sjögren syndrome

Description

Inclusion Criteria:

• Male or female patient ≥ 18 years
• Primary sjögren syndrome according of age to 2002 or 2016 classification criteria

Exclusion Criteria:

• Secondary sjögren syndrome

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of parenchymal abdnormalities.	Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration	inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenchymal abnormalities according to disease activity	Ultrasonography parenchymal abnormalities of salivary gland	inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): May 20, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 27, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: ultrasonography; salivary glands; Primary sjögren's syndrome; auto-immune disease
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: MASAI (29BRC19.0103)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending two years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No