Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

NCT06680310 | Not Yet Recruiting

• 2 other identifiers: 29BRC23.02732024-A00412-45
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with Sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (RA), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).

Conditions

Sjogren Syndrome; Dry Syndrome; Lupus; Scleroderma; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations

  The salivary gland assessment score will be evaluated according to the OMERACT score (0-3) for each group of patients.

  Baseline

Secondary Outcomes (2)

• Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.

  Baseline

• Evaluate the proportion of patients with vascular anomalies in each subgroup

  Baseline

Study Arms (3)

Sjogren syndrome

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with Sjögren

Other autoimmune diseases (Lupus/RA/Scleroderma)

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with other autoimmune diseases (Lupus/RA/Scleroderma)

Dry syndrome

Ultrasound of the parotid and submandibular salivary glands in routine care of patients with dry syndrome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Sjögren's disease, all patients with autoimmune diseases such as LUPUS, scleroderma or rheumatoid arthritis with dry syndrome, and a population of healthy controls with dry syndrome and no autoimmune disease as mentioned above.

You may qualify if:

• Major patients
• Patients fulfilling Sjogren criteria (2012 and 2016 American-European criteria) or Lupus according to ACR 2019 criteria or RA according to ACR/EULAR 2010 criteria or scleroderma according to ACR-EULAR 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease).

You may not qualify if:

• Uncooperative patient who has refused to participate in the study.
• Patients unable to understand the protocol, under guardianship or curatorship.
• Patients not affiliated to the French Social Security system.

Sponsors & Collaborators

• University Hospital, Brest: lead
• CHRU de Brest (Brest University Hospital): collaborator

Study Sites (1)

CHU Brest

Brest, France

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Scleroderma, Diffuse; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Scleroderma, Systemic; Skin Diseases

Central Study Contacts

Sandrine JOUSSE-JOULIN, Dr

CONTACT

02 98 34 72 68; sandrine.jousse-joulin@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)