NCT00920114

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

June 5, 2009

Last Update Submit

September 16, 2025

Conditions

Lupus Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • 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

    2 years

Study Arms (3)

Lupus disease

EXPERIMENTAL
Biological: blood sample

Healthy witnesses

ACTIVE COMPARATOR
Biological: blood sample

Healthy witnesses with an other auto-immune disease

ACTIVE COMPARATOR
Biological: blood sample

Interventions

blood sampleBIOLOGICAL
Healthy witnessesHealthy witnesses with an other auto-immune diseaseLupus disease

Eligibility Criteria

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

You may qualify if:

  • Lupus disease diagnosed for lupus disease arm
  • Signed assent

You may not qualify if:

  • non-compliance
  • pregnancy
  • persons without social coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hopitaux de Marseille

Marseille, France

Location

Related Publications (5)

  • Jourde-Chiche N, Whalen E, Gondouin B, Speake C, Gersuk V, Dussol B, Burtey S, Pascual V, Chaussabel D, Chiche L. Modular transcriptional repertoire analyses identify a blood neutrophil signature as a candidate biomarker for lupus nephritis. Rheumatology (Oxford). 2017 Mar 1;56(3):477-487. doi: 10.1093/rheumatology/kew439.

    PMID: 28031441BACKGROUND

  • Bettacchioli E, Chiche L, Chaussabel D, Cornec D, Jourde-Chiche N, Rinchai D. An interactive web application for exploring systemic lupus erythematosus blood transcriptomic diversity. Database (Oxford). 2024 May 28;2024:baae045. doi: 10.1093/database/baae045.

    PMID: 38805754BACKGROUND

  • Arcani R, Jouve E, Chiche L, Jourde-Chiche N. Categorization of patients with systemic lupus erythematosus using disease activity, patient-reported outcomes, and transcriptomic signatures. Clin Rheumatol. 2023 Jun;42(6):1555-1563. doi: 10.1007/s10067-023-06525-8. Epub 2023 Feb 10.

    PMID: 36759402BACKGROUND

  • Seguier J, Jouve E, Bobot M, Whalen E, Dussol B, Gentile S, Burtey S, Halfon P, Retornaz F, Chaussabel D, Chiche L, Jourde-Chiche N. Paradoxical association between blood modular interferon signatures and quality of life in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2020 Aug 1;59(8):1975-1983. doi: 10.1093/rheumatology/kez541.

    PMID: 31776548BACKGROUND

  • Chiche L, Jourde-Chiche N, Whalen E, Presnell S, Gersuk V, Dang K, Anguiano E, Quinn C, Burtey S, Berland Y, Kaplanski G, Harle JR, Pascual V, Chaussabel D. Modular transcriptional repertoire analyses of adults with systemic lupus erythematosus reveal distinct type I and type II interferon signatures. Arthritis Rheumatol. 2014 Jun;66(6):1583-95. doi: 10.1002/art.38628.

    PMID: 24644022RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Laurent CHICHE

    Assistance Publique-Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 15, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

March 1, 2012

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

FR(1)