GADD34 and Type I IFN Response Genes in SLE
GADD34-IFN
Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus
1 other identifier
observational
90
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedJuly 5, 2017
June 1, 2017
3.2 years
June 30, 2017
July 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
GADD34 and IFN response gene expression
4 years
GADD34 expression and pathology activity
4 years
GADD34 expression and pathology activity
4 years
CHOP and BiP expression
4 years
Study Arms (2)
Patients
Patients with SLE
Healthy subjects
Eligibility Criteria
Patients suffering from systemic lupus erythematosus
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 2, 2017
Study Start
January 25, 2012
Primary Completion
April 3, 2015
Study Completion
April 3, 2015
Last Updated
July 5, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share