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Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus (GADD34-LES)

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ClinicalTrials.gov Identifier: NCT02455089
Recruitment Status : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Other: GADD34 RNA level measurement. Not Applicable

Detailed Description:

Systemic lupus erythematosus (SLE) has a prevalence estimated between 1 and 6 per 10000 individuals and concerns over 30 000 patients in France for example. As of today, there isn't any reliable specific blood analysis that can be used to assess the prognosis of SLE, that means predict a SLE flare. The discovery of such a blood test could allow a better patients' monitoring in order to help doctors to better adapt treatments (lowering background treatments when they are not needed and increase them ahead of a potential flare when the risk assessment raises).

In SLE patients, a recent study shows elevated levels of GADD34 RNA in mononuclear blood cells : higher than twice the control levels for 36 of the 60 SLE patients and ten times higher than the control levels for 13 of the 60 SLE patients.

Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus
Actual Study Start Date : June 2015
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Test group

250 SLE patients : All SLE patients included in the study. Intervention : Blood analysis including GADD34 RNA level measurement every 3 months up to 1 year.

They will provided a blood sample every 3 months during a year. The result of GADD34 RNA level in mononuclear blood cells will be correlated to the clinical assessment of a SLE flare during the next 3 months.

A flare occurence will the group

Other: GADD34 RNA level measurement.

Blood analysis including GADD34 RNA level measurement is performed every 3 months up to 1 year for SLE patients.

A modal including physical exam, standard biological results and GADD34 RNA level is correlated to a SLE flare occurence in the next 3 months.

Other Name: Experimental: Test group



Primary Outcome Measures :
  1. GADD34 RNA level [ Time Frame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used. ]

    GADD34 RNA level in mononuclear blood cells in the last 3 months before a SLE flare occurence.

    RNA levels have no unit,they are rates compared with a housekeeping gene RNA level as unit.

    To avoid any bias in primary outcome, SLE Flare occurence is assessed with both patient and investigator blinded from Gadd34 RNA level.



Secondary Outcome Measures :
  1. Prognosis score of SLE flare occurence [ Time Frame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used. ]

    Prognosis score of SLE flare occurence using a modal including GADD34 RNA increase, SLEDAI score and Physician Global Assessment (PGA).

    This modal is compared to the gold standard modal which use only PGA and SLEDAI Score in term of sensibility and specificity.


  2. Pro-inflammatory cytokine blood level. [ Time Frame: Measured every 3 months, up to 1 year (5 blood samples). ]
    Correlation between GADD34 RNA increase or decrease and interferon-alpha, interferon-beta, interleukin-6 and interleukine-17 levels.


Other Outcome Measures:
  1. GADD34 RNA level in each mononuclear blood cells (B cells, T cells and monocytes). [ Time Frame: Measured once at the 2nd visit (3 months after the inclusion). ]

    GADD34 RNA level is measured respectively in B cells, T cells and monocytes and is compared with each other.

    RNA levels have no unit,they are rates compared with a housekeeping gene RNA level as unit. This outcome is measured only for 30 patients.


  2. GADD34 RNA level in non-mononuclear blood cells [ Time Frame: Measured once at the 2nd visit (3 months after the inclusion). ]

    GADD34 RNA level is measured respectively in non-mononuclear blood cells and is compared with GADD34 RNA level in mononuclear blood cells.

    RNA levels have no unit,they are rates compared with a housekeeping gene RNA level as unit. This outcome is measured only for 30 patients.




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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:

    • man and women over 18 Years old.
    • suffering from SLE (American College of Rheumatology criteria).
    • without SLE flare for 3 months.
    • with a signed consent and social security affiliation (required in France).
  • Exclusion Criteria:

    • Viral infection within 15 days.
    • Other chronic inflammatory disease.
    • People with special protection (defined in articles : L1121- §5-8 et articles L3212-§1-3 of French health care law).

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): NCT02455089


Locations
France
CHU Grenoble
Grenoble, France, 38000
groupement hospitalier mutualiste de Grenoble
Grenoble, France, 38000
Hopital européen de Marseille
Marseille, France, 13003
CHU Marseille
Marseille, France, 13005
CHR Annecy Genevois
Metz-Tessy, France, 74370
CHU Lyon sud
Pierre-Bénite, France, 69310
CHU Saint Etienne
Saint Etienne, France, 42000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Yves Cesbron, MD University Hospital of Grenoble, France.

Publications of Results:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02455089     History of Changes
Other Study ID Numbers: 38RC15.010
2015-A00493-46 ( Other Identifier: ID RCB )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No data will be be shared with non associated investigator till publication. Possibility to share after publication, through formol requirement adressed to Grenoble hospital administration (AccueilRecherche@chu-grenoble.fr)

Keywords provided by University Hospital, Grenoble:
Flare
Therapeutic adjustments
Biological Marker
Immunologic Marker
Prognosis

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases