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

NCT04212572 | Unknown

• 1 other identifier: MASAI (29BRC19.0103)
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary sjögren's Syndrome

Keywords

Primary sjögren's syndrome; ultrasonography; salivary glands; auto-immune disease

Outcome Measures

Primary Outcomes (1)

• Presence or absence of parenchymal abdnormalities.

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

  inclusion

Secondary Outcomes (1)

• Parenchymal abnormalities according to disease activity

  inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Primary sjögren syndrome

You may qualify if:

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

You may not qualify if:

• Secondary sjögren syndrome

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (3)

CHRU de Brest

Brest, 29609, France

RECRUITING

CHU de LILLE

Lille, 59037, France

NOT YET RECRUITING

CHU de MONTEPELLIER

Montpellier, 34295, France

NOT YET RECRUITING

Central Study Contacts

Valerie DEVAUCHELLE

CONTACT

2 98 34 72 64; valerie.devauchelle-pensec@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 27, 2019
• Study Start: November 20, 2019
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending two years following the publication
• 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.

Locations

FR (3)