search
Back to results

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

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
description of a lupus patient cohort
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Lupus Erythematosus focused on measuring cutaneous lupus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de BrestRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lupus cohort follow up

Arm Description

it is a descrption lupus patients study

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
January 24, 2022
Sponsor
University Hospital, Brest
search

1. Study Identification

Unique Protocol Identification Number
NCT04320680
Brief Title
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation
Acronym
CO LUPUS
Official Title
Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
May 13, 2025 (Anticipated)
Study Completion Date
May 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
cutaneous lupus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
diagnosis and follow up of a lupus cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lupus cohort follow up
Arm Type
Other
Arm Description
it is a descrption lupus patients study
Intervention Type
Other
Intervention Name(s)
description of a lupus patient cohort
Intervention Description
description of a lupus patient cohort
Primary Outcome Measure Information:
Title
Cohort lupus: epidemiologic lupus study about diagnosis and follow up
Description
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).
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sandrine jousse joulin, MD
Phone
+33 2 98 34 72 68
Email
sandrine.jousse-oulin@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
alain saraux, MD, PHD
Phone
+33 2 98 347270
Email
alain.saraux@chu-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine JOUSSE-JOULIN

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation

We'll reach out to this number within 24 hrs