Skip to main content
OpenTrials
Completed

NCT Number: NCT02455089

Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lupus Erythematosus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble, Grenoble, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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).

Treatment and study plan

GADD34 RNA level measurement.

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: GADD34-LES

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 27, 2015
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.