Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06680310

Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

This is a non-interventional study involving patients who are routinely monitored for their disease, and who typically benefit from ultrasound of the parotid and submandibular salivary glands as part of their dry mouth syndrome. Recruitment will be facilitated by the fact that these will be "general population" patients with Sjögren's disease, lupus, RA, scleroderma with dry syndrome, and control patient.

The study will be conducted over a single visit, including a clinical examination and an ultrasound scan. Ultrasound will not be blinded to the clinic, so we will need only one examiner per center.

This is a study in routine care, with no additional costs and no expected constraints. The examination will be carried out as part of their routine follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

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

Secondary outcomes

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

    Time frame: Baseline

    Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup.

  2. Evaluate the proportion of patients with vascular anomalies in each subgroup

    Time frame: Baseline

    Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine JOUSSE-JOULIN, Dr

CONTACT

[email protected]

02 98 34 72 68

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • CHRU de Brest (Brest University Hospital)

Registry information

Official study title

Prospective Multicenter Study of Ultrasound Evaluation of Salivary Glands in Patients with Sjögren's Disease Compared with Patients with Connective Tissue Diseases (lupus, Scleroderma, Rheumatoid Arthritis) and Healthy Subjects with Dry Syndromes

Acronym: COUGAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.