Systemic Lupus Erythematosus Within the Framework of the... | NCT04320680

Studies
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation

NCT04320680

Sponsor

University Hospital, Brest

Status

Recruiting

Last Update Posted

Feb 4, 2025Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Systemic Lupus Erythematosus

Interventions

description of a lupus patient cohort

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2020Actual

Primary Completion Date

May 13, 2025Estimated

Completion Date

May 13, 2025Estimated

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 24, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2025

Last Update Posted Date

Feb 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

Detailed Description

all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lupus cohort follow up	Other	it is a descrption lupus patients study	Other: description of a lupus patient cohort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
description of a lupus patient cohort	Other	description of a lupus patient cohort	lupus cohort follow up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort lupus: epidemiologic lupus study about diagnosis and follow up	epidemiologic lupus study in collecting data ( description of the population, biologic and immunologic data collection, data of articular damges with xrays datas) about Diagnosis and follow up of a cohort lupus in a multidisciplibnary consultation in brest hospital ( France).	five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
With written consentment

Exclusion Criteria:

patients less than 18 years old
refusing to participate
Under legal protection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sandrine jousse joulin, MD	Contact	+33 2 98 34 72 68		sandrine.jousse-oulin@chu-brest.fr
alain saraux, MD, PHD	Contact	+33 2 98 347270		alain.saraux@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest			France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided