Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-04-15 @ 8:58 PM
Study NCT ID:
NCT03206359
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GADD34 and Type I IFN Response Genes in SLE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-03', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GADD34 expression in SLE patients', 'timeFrame': '4 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'GADD34 and IFN response gene expression', 'timeFrame': '4 years', 'description': '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'}, {'measure': 'GADD34 expression and pathology activity', 'timeFrame': '4 years', 'description': 'Evaluation of the relation between GADD34 overexpression and the activity of the pathology'}, {'measure': 'GADD34 expression and pathology activity', 'timeFrame': '4 years', 'description': 'Evaluation of the relation between GADD34 overexpression and the presence of anti-DNA antibodies.'}, {'measure': 'CHOP and BiP expression', 'timeFrame': '4 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unfolded Protein Response', 'GADD34', 'Type I IFN', 'IFN response genes', 'Type II IFN', 'anti-DNA autoantibodies'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from systemic lupus erythematosus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man and woman over 18 years old.\n* Patients suffering from SLE (SLICC criteria)\n* Patients having given their "Non-opposition"\n* Patients with social security affiliation (required in France)\n\nExclusion Criteria:\n\n* Patients suffering from other auto-immune disease (except SAPL, thyroiditis, and Gougerot Sjogren syndrome)\n* Patients with viral infection within 15 days\n* People with special protection (defined in articles L1121-§5-8 and articles L3212-§1-3 of French health care law)'}, 'identificationModule': {'nctId': 'NCT03206359', 'acronym': 'GADD34-IFN', 'briefTitle': 'GADD34 and Type I IFN Response Genes in SLE', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': '38RC17.197'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with SLE'}, {'label': 'Healthy subjects'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}