Estimate of the Activity and the Forecast of the Lupus Disease of the Adult by a Transcriptomic Score (STUDY LU-PUCE) (LU-PUCE)

September 16, 2025 updated by: Assistance Publique Hopitaux De Marseille
Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Locations

  • France
      • Marseille, France
        • Assistance Publique-Hôpitaux de Marseille

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Lupus disease diagnosed for lupus disease arm
  • Signed assent

Exclusion Criteria:

  • non-compliance
  • pregnancy
  • persons without social coverage

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lupus disease
Biological: blood sample
Active Comparator: Healthy witnesses
Biological: blood sample
Active Comparator: Healthy witnesses with an other auto-immune disease
Biological: blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify the genes expressed during the disease to allow the calculation of a transcriptomic score and study the correlation of this transcriptionnal score with the SLEDAI score
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify genes correlated in various histological classes of lupus renal disease and types of pushes of the disease; to allow the calculation of a transcriptomic score and its correlation with the BILAG score
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Laurent CHICHE, Assistance Publique-Hôpitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimated)

June 15, 2009

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/04
  • 2009-A00257-50

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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