Not yet recruitingOBSERVATIONAL

Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

The COUGAR study is comparing ultrasound scans of major spit glands (in your cheeks and under your jaw) in people with certain autoimmune diseases like Sjögren's syndrome, lupus, scleroderma, and rheumatoid arthritis. They are also looking at people who have dry mouth symptoms but don't have these specific autoimmune conditions. The main goal is to see if these ultrasound scans can help doctors understand and identify these conditions better. This is a simple, one-off visit during your routine check-up, involving a physical exam and an ultrasound. It's a way to learn more about how these diseases affect the body without any extra tests or changes to your usual care.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Brest

Enrolment target

501

Start

01 Dec 2024

Estimated completion

01 Dec 2025

Sjogren Syndrome Dry Syndrome Lupus Scleroderma Rheumatoid Arthritis

What is this study about?

The COUGAR study is looking into how useful ultrasound scans are for understanding certain autoimmune conditions. Autoimmune diseases happen when your body's immune system, which usually fights off infections, mistakenly attacks healthy parts of your own body. This study focuses on conditions like Sjögren's syndrome, lupus, scleroderma, and rheumatoid arthritis. Researchers are particularly interested in how these conditions affect your main salivary glands – these are the glands in your cheeks (parotid) and under your jaw (submandibular) that produce spit. Many people with these conditions experience dry mouth, and an ultrasound can create a picture of these glands.

The main aim is to compare the ultrasound images from people with these autoimmune diseases to those who have dry mouth but not these specific conditions. By doing this, the researchers hope to find out if there are common patterns or key differences that can be seen on the scans. This information could eventually help doctors to diagnose these conditions more accurately or to understand how they are progressing, potentially leading to better care for patients in the future.

This study is designed to fit in with your regular medical appointments, without adding any extra burden or cost. It's a chance to contribute to medical knowledge simply by agreeing to have an ultrasound as part of your routine check-up, especially if an ultrasound of your salivary glands is already something your doctor normally recommends for your dry mouth symptoms.

Key takeaways

The study looks at salivary glands using ultrasound in people with autoimmune diseases.
It aims to better understand conditions like Sjögren’s, lupus, and rheumatoid arthritis.
Participation involves a single visit: a physical exam and an ultrasound.
This study fits into your routine medical care and has no extra costs or risks.
Your involvement helps advance medical knowledge for these conditions.

Who may be eligible?

To join this study, you need to be an adult. You must also have a confirmed diagnosis of Sjögren's syndrome (based on specific medical guidelines), lupus, rheumatoid arthritis (RA), or scleroderma. The study also includes a group of people who have dry mouth symptoms but do not have any of these specific autoimmune diseases.

There are a few reasons why someone might not be able to join. If you're unable to cooperate or understand the study details, or if you're under guardianship, you won't be able to participate. Also, because this study is being conducted in France, participants need to be part of the French Social Security system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult?
Do you have a diagnosis of Sjögren's, lupus, rheumatoid arthritis, or scleroderma, OR do you have dry mouth without these specific conditions?
Are you able to understand and cooperate with the study instructions?
Are you part of the French Social Security system (if applicable where the study is being run)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will be very easy and fits into your routine care. You will have just one visit specifically for the study. During this visit, a doctor will perform a physical examination, and you will have an ultrasound scan of your main salivary glands (the ones in your cheeks and under your jaw). This ultrasound is often something doctors suggest anyway if you have dry mouth symptoms. There are no extra tests, medications, or follow-up appointments directly related to this study. It's simply making use of a check-up you might already be having.

Potential risks and benefits

By taking part, you could help doctors learn more about autoimmune diseases and how they affect the salivary glands, potentially leading to better long-term care for patients. As the study involves standard care like a physical exam and ultrasound, there are no expected additional risks beyond what you might encounter during your usual medical appointments. You are free to ask questions at any time and can choose to withdraw from the study without giving a reason, and this will not affect your regular medical care.

Locations (1)

CHU Brest
Verified postcode
Brest, France

Common questions

What is an autoimmune disease?

It's a condition where your body's immune system accidentally attacks its own healthy tissues instead of fighting off germs. This can cause problems in different parts of your body.

What are salivary glands?

These are glands in your mouth that make spit (saliva). They help you chew, swallow, and digest food, and they keep your mouth healthy. The main ones are in your cheeks and under your jaw.

Will this study change my current treatment?

No, this study will not affect your current treatment or medical care. It's designed to observe and gather information during your routine check-ups.

Do I have to pay to be in this study?

No, there are no additional costs for participating in this study. It uses procedures that are often part of your regular medical care.

What is an ultrasound?

An ultrasound is a safe and painless medical test that uses sound waves to create live pictures from inside the body. For your salivary glands, it involves a small device placed on your skin.

How to find out more

Sandrine JOUSSE-JOULIN, Dr

sandrine.jousse-joulin@chu-brest.fr 02 98 34 72 68 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.