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

Primary Purpose

Sjogren's Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood, fluid, sells and urine samples
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sjogren's Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de BrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Sjögren patients

Non-Sjögren witnesses

Arm Description

patients diagnosed Sjögren

patients diagnosed no Sjögren

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Number of patients with rheumatological manifestations
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Number of patients with dermatological manifestations
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Description diagnostic performance of new tests
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....
Disease evolution criteria
modification of the ESSDAI at each visit

Full Information

First Posted
December 23, 2019
Last Updated
April 12, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04931160
Brief Title
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Acronym
BRAISES-DiaPSS
Official Title
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
February 10, 2035 (Anticipated)
Study Completion Date
February 10, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sjögren patients Non-Sjögren controls (retrospective)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sjögren patients
Arm Type
Active Comparator
Arm Description
patients diagnosed Sjögren
Arm Title
Non-Sjögren witnesses
Arm Type
Other
Arm Description
patients diagnosed no Sjögren
Intervention Type
Other
Intervention Name(s)
Blood, fluid, sells and urine samples
Intervention Description
Blood, fluid, sells and urine samples will be collected.
Primary Outcome Measure Information:
Title
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
Description
Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
Description
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Time Frame
10 years
Title
Number of patients with rheumatological manifestations
Description
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Time Frame
10 years
Title
Number of patients with dermatological manifestations
Description
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Time Frame
10 years
Title
Description diagnostic performance of new tests
Description
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....
Time Frame
10 years
Title
Disease evolution criteria
Description
modification of the ESSDAI at each visit
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Devauchelle, MD,PhD
Phone
33 (0) 2 98 34 72 64
Email
valerie.devauchelle-pensec@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Devauchelle
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie DEVAUCHELLE

12. IPD Sharing Statement

Learn more about this trial

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

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