CompletedNCT00920114LU-PUCEUpdated Sep 18, 2025

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

An interventional study of blood sample in Lupus Disease, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 80
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Lupus Disease

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Lupus disease diagnosed for lupus disease arm
Signed assent

Exclusion criteria

Exclusion Criteria:

non-compliance
pregnancy
persons without social coverage

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 80 participants (estimated)

Study arms

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

Interventions

Biologicalblood sample

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Assistance Publique-Hopitaux de Marseille
Marseille, France

References and documents

Publications

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. PubMed 28031441 ↗
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. PubMed 38805754 ↗
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. PubMed 36759402 ↗
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. PubMed 31776548 ↗
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. PubMed 24644022 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00920114
Lead sponsor: Assistance Publique Hopitaux De Marseille
First posted: Jun 15, 2009
Start date: May 2009
Primary completion: May 2011
Completion: Mar 2012
Last update: Sep 18, 2025

Study contacts

Laurent CHICHE

principal investigator · Assistance Publique-Hôpitaux de Marseille

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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