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

• Conditions: Primary sjögren's Syndrome

• Registration Number: NCT04212572
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Status Verified: 2019-12
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-26
• Last Update Submitted: 2019-12-26
• Study First Posted: 2019-12-27
• Last Update Posted: 2019-12-27
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of parenchymal abdnormalities.	inclusion	Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration

Secondary Outcome Measures

Name	Time	Method
Parenchymal abnormalities according to disease activity	inclusion	Ultrasonography parenchymal abnormalities of salivary gland

Trial Locations

Locations (3)

CHRU de Brest; 🇫🇷 Brest, France

CHU de MONTEPELLIER; 🇫🇷 Montpellier, France

CHU de LILLE; 🇫🇷 Lille, France