Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04931160

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

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

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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

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