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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

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date January 25, 2022
Actual Study Start Date  ICMJE October 13, 2020
Estimated Primary Completion Date May 13, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)		 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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)		 Cohort lupus: diagnosis ans follow up [ Time Frame: five years ]
Diagnosis and follow up of a cohort lupus in a multidisciplibnary consultation in brest hospital ( France)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation
Official Title  ICMJE Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Other: description of a lupus patient cohort
description of a lupus patient cohort
Study Arms  ICMJE lupus cohort follow up
it is a descrption lupus patients study
Intervention: Other: description of a lupus patient cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 13, 2025
Estimated Primary Completion Date May 13, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320680
Other Study ID Numbers  ICMJE 29BRC20.0073
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party University Hospital, Brest
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Brest
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Brest
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP