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Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation (CO LUPUS)

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ClinicalTrials.gov Identifier: NCT04320680
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief Summary:
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: description of a lupus patient cohort Not Applicable

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: diagnosis and follow up of a lupus cohort
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : May 13, 2025
Estimated Study Completion Date : May 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
lupus cohort follow up
it is a descrption lupus patients study
 Other: description of a lupus patient cohort
description of a lupus patient cohort


Outcome Measures
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Primary Outcome Measures :
  1. Cohort lupus: epidemiologic lupus study about diagnosis and follow up [ Time Frame: five years ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320680


Contacts
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Contact: sandrine jousse joulin, MD +33 2 98 34 72 68 sandrine.jousse-oulin@chu-brest.fr
Contact: alain saraux, MD, PHD +33 2 98 347270 alain.saraux@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France
Contact: Sandrine JOUSSE-JOULIN         
Sponsors and Collaborators
University Hospital, Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04320680    
Other Study ID Numbers: 29BRC20.0073
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
cutaneous lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases