Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-07 @ 6:30 AM
Study NCT ID:
NCT03575156
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2018-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients', 'timeFrame': 'At baseline (Day 0) and 12 months from baseline'}], 'secondaryOutcomes': [{'measure': 'Disease activity scores for SLE patients', 'timeFrame': 'At baseline (Day 0) and 12 months from baseline', 'description': 'Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)'}, {'measure': 'Disease activity scores for SSc patients', 'timeFrame': 'At baseline (Day 0) and 12 months from baseline', 'description': 'Rodnan score'}, {'measure': 'Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients', 'timeFrame': 'At baseline (Day 0) and 12 months from baseline'}, {'measure': 'Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc', 'timeFrame': 'At baseline (Day 0) and 12 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Systemic Scleroderma', 'autoimmunity', 'microparticles', 'platelets'], 'conditions': ['Systemic Lupus Erythematosus', 'Systemic Scleroderma']}, 'descriptionModule': {'briefSummary': 'Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.', 'detailedDescription': "Systemic lupus erythematosus (SLE) and systemic scleroderma (SSc) are two rare and potentially life-threatening auto-immune systemic diseases. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Microparticles (MPs) are small extracellular vesicles formed from activated cells including endothelial cells and platelets. Preliminary data from our lab indicate that these MPs might play a key role in SLE and SSc physiopathology. In fact, MPs from patients with SLE aggregates with T regulator lymphocytes (LTregs) and decrease their activity, thereby promoting auto-immunity. Some works also indicate that MPs might cargo DNA to the immune system, also promoting auto-immunity. The investigators hypothesized that MPs levels might be a prognostic factor in SLE and SSc and that studying the molecular mechanisms involved could provide new therapeutic targets.\n\nOur study will recruit 100 patients with SLE or SSc followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study circulating microparticles. Fundamental research will be realized on patients' sample to study molecular mechanisms involved.\n\nClinical and biological disease activity, treatment and outcomes will be studied in correlation with MPs to describe their potential prognostic role. Patients will be followed at regular intervals as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same times as those drawn for clinical purposes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of systemic lupus erythematosus or systemic sclerosis;\n* age ≥ 18 years;\n* being affiliated to health insurance, willing to participate and to sign informed consent.\n\nExclusion Criteria:\n\n* pregnant or breastfeeding women;\n* patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)'}, 'identificationModule': {'nctId': 'NCT03575156', 'acronym': 'MICROLUPS', 'briefTitle': "Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': "Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis", 'orgStudyIdInfo': {'id': 'CHUBX 2017/54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systemic lupus erythematosus (SLE)', 'interventionNames': ['Biological: blood sample', 'Biological: urine sample']}, {'type': 'EXPERIMENTAL', 'label': 'systemic scleroderma (SSc)', 'interventionNames': ['Biological: blood sample', 'Biological: urine sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': '36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation', 'armGroupLabels': ['Systemic lupus erythematosus (SLE)', 'systemic scleroderma (SSc)']}, {'name': 'urine sample', 'type': 'BIOLOGICAL', 'description': '6 ml', 'armGroupLabels': ['Systemic lupus erythematosus (SLE)', 'systemic scleroderma (SSc)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux - service de rhumatologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Christophe RICHEZ, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}