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

NCT ID: NCT04931160

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2035-02-10

Brief Summary

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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

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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.

Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

* Sjögren patients
* Non-Sjögren controls (retrospective)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sjögren patients

patients diagnosed Sjögren

Group Type ACTIVE_COMPARATOR

Blood, fluid, sells and urine samples

Intervention Type OTHER

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

Non-Sjögren witnesses

patients diagnosed no Sjögren

Group Type OTHER

Blood, fluid, sells and urine samples

Intervention Type OTHER

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

Interventions

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Blood, fluid, sells and urine samples

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie Devauchelle

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valérie Devauchelle, MD,PhD

Role: CONTACT

33 (0) 2 98 34 72 64

Facility Contacts

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Valérie DEVAUCHELLE

Role: primary

Other Identifiers

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BRAISE DiaPSS

Identifier Type: -

Identifier Source: org_study_id

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