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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Lupus Erythematosus

Treatments: Other: GADD34 RNA level measurement.

Study type: Interventional

Funder types: Other

Identifiers

NCT02455089

38RC15.010

2015-A00493-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 1 patient group

Test group

Experimental group

Description:

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

Treatment:

Other: GADD34 RNA level measurement.