B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome (BRAISES-DiaPSS)

June 25, 2026 updated by: University Hospital, Brest
The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.

  • Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.
  • Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Valérie DEVAUCHELLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sjögren patients
patients diagnosed Sjögren
Other: Blood, fluid, sells and urine samples
Blood, fluid, sells and urine samples will be collected.
Other: Non-Sjögren witnesses
patients diagnosed no Sjögren
Other: Blood, fluid, sells and urine samples
Blood, fluid, sells and urine samples will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
Time Frame: Inclusion
Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.
Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
Time Frame: 10 years
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
10 years
Number of patients with rheumatological manifestations
Time Frame: 10 years
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
10 years
Number of patients with dermatological manifestations
Time Frame: 10 years
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
10 years
Description diagnostic performance of new tests
Time Frame: 10 years
after evaluation of all différents test performed added to the classical items of the ACR 2017: ie ultrasound parenchymal abnormalities, sub population of B cells....
10 years
Disease evolution criteria
Time Frame: 10 years
modification of the ESSDAI at each visit
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Valérie Devauchelle, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Estimated)

February 10, 2035

Study Completion (Estimated)

February 10, 2035

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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