Cohort of patients with suspected primary Sjögren syndrome
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT04931160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults suspected of having primary Sjögren syndrome based on clinical or biological criteria.
Not a fit: Patients who are pregnant or lactating, or those who refuse to participate, may not benefit from this study.
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 performed: While there have been studies on Sjögren syndrome, this specific approach to evaluating diagnostic criteria against expert assessments is relatively novel.
Eligibility criteria
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 this trial is running
Brest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.