Clinical trial NCT02455089: Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus
Official title: Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus
Keywords: Flare
Therapeutic adjustments
Biological Marker
Immunologic Marker
Prognosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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).

Primary outcomes:
measure: GADD34 RNA level
timeFrame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.
Secondary outcomes:
measure: Prognosis score of SLE flare occurence
timeFrame: Measured every 3 months, up to 1 year (5 blood samples).The Last result before a SLE flare occurence will be used.
measure: Pro-inflammatory cytokine blood level.
timeFrame: Measured every 3 months, up to 1 year (5 blood samples).
Other outcomes:
measure: GADD34 RNA level in each mononuclear blood cells (B cells, T cells and monocytes).
timeFrame: Measured once at the 2nd visit (3 months after the inclusion).
measure: GADD34 RNA level in non-mononuclear blood cells
timeFrame: Measured once at the 2nd visit (3 months after the inclusion).
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Grenoble
country: France
facility: groupement hospitalier mutualiste de Grenoble
city: Marseille
country: France
facility: Hopital européen de Marseille
city: Marseille
country: France
facility: CHU Marseille
city: Metz-Tessy
country: France
facility: CHR Annecy Genevois
city: Pierre-Bénite
country: France
facility: CHU Lyon sud
city: Saint Etienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: University Hospital of Grenoble, France.
name: Jean-Yves Cesbron, MD
role: PRINCIPAL_INVESTIGATOR
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