Cohort of patients with suspected primary Sjögren syndrome
Official title: B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Run by University Hospital, Brest · NCT04931160 · Data updated 2026-11-12
This study is testing different ways to diagnose primary Sjögren syndrome in patients who might have it, by comparing results from various tests to expert opinions over a long period of time.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Status | Recruiting |
| Started | February 10, 2020 |
| Main results expected | February 10, 2035 |
| Study ends | February 10, 2035 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT04931160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults suspected of having primary Sjögren syndrome based on clinical or biological criteria.
✕Probably not a fit
Patients who are pregnant or lactating, or those who refuse to participate, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the diagnostic performance of various classification criteria for primary Sjögren syndrome (pSS) against a gold standard established by expert physicians. It is a single-center, prospective intervention that will collect clinical, biological, and imaging data from patients suspected of having pSS. Participants will be monitored over a period of up to 10 years, with samples of blood, fluid, cells, and urine collected at specified intervals. Additionally, non-Sjögren controls will also be followed to compare findings.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing primary Sjögren syndrome, leading to better patient management.
How similar studies have gone: While there have been studies on Sjögren syndrome, this specific approach to evaluating diagnostic criteria against expert assessments is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Major patient * Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...) * Patient affiliated with Social Security * Patient who has signed written informed consent Exclusion Criteria: * Refusal to participate * Pregnant and lactating woman
Where it's running
-
CHRU de Brest
Brest, France Recruiting
Study contacts
- Principal investigator: Valérie Devauchelle — Chru Brest
- Study coordinator: Valérie Devauchelle, MD,PhD
- Email: valerie.devauchelle-pensec@chu-brest.fr
- Phone: 33 (0) 2 98 34 72 64
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.