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

February 20, 2019 updated by: University Hospital, Grenoble
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

143

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
      • Grenoble, France, 38000
        • CHU Grenoble
      • Grenoble, France, 38000
        • Groupement Hospitalier Mutualiste de Grenoble
      • Marseille, France, 13005
        • CHU Marseille
      • Marseille, France, 13003
        • Hôpital Européen de Marseille
      • Metz-Tessy, France, 74370
        • CHR Annecy Genevois
      • Pierre-Bénite, France, 69310
        • CHU Lyon Sud
      • Saint Etienne, France, 42000
        • CHU Saint Etienne

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

Genders Eligible for Study

All

Description

  • 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).

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Experimental: Test group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.
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.
Measured every 3 months, up to 1 year (5 blood samples).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured once at the 2nd visit (3 months after the inclusion).
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.
Measured once at the 2nd visit (3 months after the inclusion).

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Yves Cesbron, MD, University Hospital of Grenoble, France.

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 (ACTUAL)

June 1, 2015

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (ESTIMATE)

May 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.010
  • 2015-A00493-46 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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)

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.

Clinical Trials on Lupus Erythematosus

Clinical Trials on GADD34 RNA level measurement.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe