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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920114
First Posted: June 15, 2009
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique Hopitaux De Marseille
  Purpose
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.

Condition Intervention
Lupus Disease Biological: blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lupus disease diagnosed for lupus disease arm
  • Signed assent

Exclusion Criteria:

  • non-compliance
  • pregnancy
  • persons without social coverage
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920114


Locations
France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Laurent CHICHE Assistance Publique-Hôpitaux de Marseille
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille, Direction de la recherche
ClinicalTrials.gov Identifier: NCT00920114     History of Changes
Other Study ID Numbers: 2009/04
2009-A00257-50
First Submitted: June 5, 2009
First Posted: June 15, 2009
Last Update Posted: March 13, 2012
Last Verified: March 2012