Sjogren SyndromeCOUGARNCT06680310
Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)
An observational study of Sjogren Syndrome and Dry Syndrome, run by University Hospital, Brest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sjogren Syndrome, Dry Syndrome, Lupus
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Brest
Brest
Sandrine JOUSSE-JOULIN, Dr, 02 98 34 72 68, sandrine.jousse-joulin@chu-brest.fr
About this study
Official 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
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).
Read the detailed description
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.
- Conditions
- Sjogren Syndrome, Dry Syndrome, Lupus, Scleroderma, Rheumatoid Arthritis
- Medical subject headings
- Sjogren's Syndrome, Scleroderma, Diffuse, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.
Evaluate the proportion of patients with B-mode ultrasound abnormalities (0-3) in each subgroup.
Measured: Baseline
Evaluate the proportion of patients with vascular anomalies in each subgroup
Study of the contribution of Doppler ultrasound to the study of salivary gland vascularization in each subgroup
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 501 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- CHRU de Brest (Brest University Hospital)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680310
- Sponsor's protocol ID
- 29BRC23.0273
- Other IDs
- 2024-A00412-45
- Acronym
- COUGAR
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06680310
- Acronym / sponsor ID
- COUGAR / 29BRC23.0273
- Conditions
- Sjogren Syndrome, Dry Syndrome, Lupus, Scleroderma, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 501 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- CHRU de Brest (Brest University Hospital)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Evaluate the proportion of patients with ultrasound abnormalities in each subgroup.
Time frame: Baseline
Evaluate the proportion of patients with vascular anomalies in each subgroup
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren Syndrome and Dry Syndrome, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine JOUSSE-JOULIN, Dr (02 98 34 72 68, sandrine.jousse-joulin@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rate of patients with structural anomalies of the salivary glands, for each of three populations (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.