NCT04320680

Brief Summary

Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

4.6 years

First QC Date

March 23, 2020

Last Update Submit

February 3, 2025

Conditions

Systemic Lupus Erythematosus

Keywords

cutaneous lupus

Outcome Measures

Primary Outcomes (1)

  • 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).

    five years

Study Arms (1)

lupus cohort follow up

OTHER

it is a descrption lupus patients study

Other: description of a lupus patient cohort

Interventions

description of a lupus patient cohortOTHER

description of a lupus patient cohort

lupus cohort follow up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
  • With written consentment

You may not qualify if:

  • patients less than 18 years old
  • refusing to participate
  • Under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, France

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

sandrine jousse joulin, MD

CONTACT

+33 2 98 34 72 68sandrine.jousse-oulin@chu-brest.fr

alain saraux, MD, PHD

CONTACT

+33 2 98 347270alain.saraux@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: diagnosis and follow up of a lupus cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

October 13, 2020

Primary Completion

May 13, 2025

Study Completion

May 13, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
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

Locations

FR(1)