Systemic Lupus ErythematosusGADD34-IFNNCT03206359
GADD34 and Type I IFN Response Genes in SLE
An observational study of Systemic Lupus Erythematosus, run by University Hospital, Grenoble.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2012to 3 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from systemic lupus erythematosus
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
Official title: Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus
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.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Unfolded Protein Response, GADD34, Type I IFN, IFN response genes, Type II IFN, anti-DNA autoantibodies
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with SLE | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (4)
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
Measured: 4 years
GADD34 expression and pathology activity
Evaluation of the relation between GADD34 overexpression and the activity of the pathology
Measured: 4 years
GADD34 expression and pathology activity
Evaluation of the relation between GADD34 overexpression and the presence of anti-DNA antibodies.
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start25 Jan 2012
- Primary completion3 Apr 2015
- Study completion3 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206359
- Sponsor's protocol ID
- 38RC17.197
- Acronym
- GADD34-IFN
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03206359
- Acronym / sponsor ID
- GADD34-IFN / 38RC17.197
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Unfolded Protein Response, GADD34, Type I IFN, IFN response genes, Type II IFN, anti-DNA autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 3 Apr 2015 (actual)
- Study completion
- 3 Apr 2015 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with SLE |
| Healthy subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from systemic lupus erythematosus
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GADD34 expression in SLE patients
Time frame: 4 years
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 secondary outcomes
GADD34 and IFN response gene expression
Time frame: 4 years
GADD34 expression and pathology activity
Time frame: 4 years
GADD34 expression and pathology activity
Time frame: 4 years
CHOP and BiP expression
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Active, not recruitingPhase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus Nephritis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GADD34 expression in SLE patients (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.