Actively Recruiting
B-dependant Rare AutoImmune diseases - Cohort of Patients With Suspected Diagnosis of Primary Sjogren Syndrome
Led by University Hospital, Brest · Updated on 2023-04-13
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy of various classification criteria for primary Sjogren syndrome (pSS) by comparing them to the diagnosis made by expert doctors after a standardized assessment. This single-center, prospective study aims to improve understanding of how well these criteria identify pSS in patients suspected of having this autoimmune condition. Participants suspected of pSS will be divided into two groups: those diagnosed with Sjogren syndrome and those not diagnosed (controls). The study involves collecting standardized biological, clinical, imaging, and pathology data. Blood, fluid, cell, and urine samples will be collected at baseline, 4 years, and 10 years for Sjogren patients, while controls will have follow-up visits and sample collection at baseline and 4 years. Participants will be followed over multiple years with visits at inclusion, 2, 3, 4, 6, 8, and 10 years for the Sjogren group, and at inclusion and 4 years for controls. The study will monitor disease manifestations, diagnostic test performance, and disease evolution using tools such as the ESSDAI index. Safety and diagnostic outcomes will be regularly assessed throughout the study, which lasts up to 10 years.
CONDITIONS
Brief Title
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Suspected primary Sjogren syndrome based on clinical or biological signs such as dry eyes, dry mouth, arthritis, parotid swelling, neuropathy, or kidney/lung disease
- Affiliated with Social Security
- Signed written informed consent to participate
You will not qualify if you...
- Refusal to participate in the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants with suspected primary Sjögren syndrome are followed over time with clinical, biological, and imaging assessments.
Visits at inclusion, 2, 3, 4, 6, 8, and 10 years; blood, fluid, cells, and urine samples collected at inclusion, 4 years, and 10 years
Trial Site Locations
Total: 1 location
1
CHRU de Brest
Brest, France
Actively Recruiting
Research Team
V
Valérie Devauchelle, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2