Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 143
- Locations
- 14
- Primary Endpoint
- GADD34 RNA level
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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).
Outcomes
Primary Outcomes
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
- Prognosis score of SLE flare occurence(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.(Measured every 3 months, up to 1 year (5 blood samples).)