Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Sjogren's Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorUniversity Hospital, Brest
Academic / other
Locations1 site (Brest)
StatusRecruiting
StartedFebruary 10, 2020
Main results expectedFebruary 10, 2035
Study endsFebruary 10, 2035
Registry record updatedJune 26, 2026
Trial IDNCT04931160 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.