B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

NCT04931160 | Recruiting DMC

• 1 other identifier: BRAISE DiaPSS
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)

  Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.

  Inclusion

Secondary Outcomes (5)

• Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure

  10 years

• Number of patients with rheumatological manifestations

  10 years

• Number of patients with dermatological manifestations

  10 years

• Description diagnostic performance of new tests

  10 years

• Disease evolution criteria

  10 years

Study Arms (2)

Sjögren patients

ACTIVE COMPARATOR

patients diagnosed Sjögren

Other: Blood, fluid, sells and urine samples

Non-Sjögren witnesses

OTHER

patients diagnosed no Sjögren

Other: Blood, fluid, sells and urine samples

Interventions

Blood, fluid, sells and urine samples OTHER

Blood, fluid, sells and urine samples will be collected.

Non-Sjögren witnesses; Sjögren patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate
• Pregnant and lactating woman

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, France

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Blood Specimen Collection; Fluid Therapy

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Valérie Devauchelle

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Devauchelle, MD,PhD

CONTACT

33 (0) 2 98 34 72 64; valerie.devauchelle-pensec@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Sjögren patients * Non-Sjögren controls (retrospective)

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: June 18, 2021
• Study Start: February 10, 2020
• Primary Completion (Estimated): February 10, 2035
• Study Completion (Estimated): February 10, 2035
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

FR (1)