GADD34 and Type I IFN Response Genes in SLE

Systemic Lupus Erythematosus Clinical Trial

— GADD34-IFN  

Official title:

Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206359
• Other study ID #: 38RC17.197
• Status: Completed
• Phase: N/A
• First received: June 30, 2017
• Last updated: July 3, 2017
• Start date: January 25, 2012
• Est. completion date: April 3, 2015

Study information

• Verified date: June 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1 (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2 alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR). Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral infection in murine models. We investigate here the expression of GADD34 in systemic lupus erythematosus (SLE), in which type I IFN has an important pathogenic role.

We report a case-control study on GADD34 gene expression in PBMC (peripheral blood mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30). The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is measured by quantitative PCR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 3, 2015
• Est. primary completion date: April 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man and woman over 18 years old.

• Patients suffering from SLE (SLICC criteria)

• Patients having given their "Non-opposition"

• Patients with social security affiliation (required in France)

Exclusion Criteria:

• Patients suffering from other auto-immune disease (except SAPL, thyroiditis, and Gougerot Sjogren syndrome)

• Patients with viral infection within 15 days

• People with special protection (defined in articles L1121-§5-8 and articles L3212-§1-3 of French health care law)

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GADD34 expression in SLE patients	Evaluation of GADD34 expression in PBMC of patients suffering from SLE compared to GADD34 expression in PBMC of healthy subjets. GADD34 gene expression level is quantified in the PBMC by quantitative PCR	4 years
Secondary	GADD34 and IFN response gene expression	Evaluation of the relation between IFN response gene expression and GADD34 expression in PBMC of patients suffering from SLE. IFN response gene and GADD34 expression level is quantified in the PBMC by quantitative PCR	4 years
Secondary	GADD34 expression and pathology activity	Evaluation of the relation between GADD34 overexpression and the activity of the pathology	4 years
Secondary	GADD34 expression and pathology activity	Evaluation of the relation between GADD34 overexpression and the presence of anti-DNA antibodies.	4 years
Secondary	CHOP and BiP expression	Evaluation of the expression of other genes of UPR (like CHOP and BiP) in PBMC of patients with SLE, compared to the expression of these genes in PBMC of healthy subjets.	4 years