- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320680
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation (CO LUPUS)
February 3, 2025 updated by: University Hospital, Brest
Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sandrine jousse joulin, MD
- Phone Number: +33 2 98 34 72 68
- Email: sandrine.jousse-oulin@chu-brest.fr
Study Contact Backup
- Name: alain saraux, MD, PHD
- Phone Number: +33 2 98 347270
- Email: alain.saraux@chu-brest.fr
Study Locations
-
-
-
Brest, France
- Recruiting
- CHRU de Brest
-
Contact:
- Sandrine JOUSSE-JOULIN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: lupus cohort follow up
it is a descrption lupus patients study
|
description of a lupus patient cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2020
Primary Completion (Estimated)
May 13, 2025
Study Completion (Estimated)
May 13, 2025
Study Registration Dates
First Submitted
March 23, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC20.0073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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