Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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 .

Layout table for study information
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

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




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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
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
Layout table for location information
France
CHRU de Brest Recruiting
Brest, France
Contact: Sandrine JOUSSE-JOULIN         
Sponsors and Collaborators
University Hospital, Brest
Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases