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NCT04212572 Clinical Trial

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

Primary sjögren's Syndrome Clinical Trial

— MASAÏ  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04212572
Other study ID # MASAI (29BRC19.0103)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date May 20, 2020

Study information
Verified date December 2019
Source University Hospital, Brest
Contact Valerie DEVAUCHELLE
Phone 2 98 34 72 64
Email valerie.devauchelle-pensec@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 242
Est. completion date May 20, 2020
Est. primary completion date May 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest
France CHU de LILLE Lille
France CHU de MONTEPELLIER Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence or absence of parenchymal abdnormalities. Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration inclusion
Secondary Parenchymal abnormalities according to disease activity Ultrasonography parenchymal abnormalities of salivary gland inclusion
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