[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654927":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":25,"collaborators":13,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":13,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":13,"enrollmentInfo":38,"targetDuration":13,"studyType":41,"phases":13,"briefSummary":42,"conditions":43,"keywords":46,"overallStatus":53,"whyStopped":13,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Serum Myeloperoxidase-DNA (MPO-DNA) Complex Concentration","Circulating levels of myeloperoxidase-DNA (MPO-DNA) complexes, measured in optical density (OD) units or ng\u002FmL using an enzyme-linked immunosorbent assay (ELISA), to evaluate neutrophil extracellular trap (NET) formation and compare active versus inactive SLE patients.","Baseline",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_CONTROL","CROSS_SECTIONAL","Adult and adolescent patients (older than 16 years) diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, attending the Rheumatology, Rehabilitation and Physical Medicine Department and the Clinical Pathology Department at Assiut University Hospitals. The cohort comprises both active SLE patients and age- and sex-matched inactive SLE patients.",[19,22],{"label":20,"type":13,"description":21,"interventionNames":13},"Active SLE Patients","Consists of 45 patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria, presenting with active disease as determined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Serum samples are collected to measure circulating myeloperoxidase-DNA (MPO-DNA) complexes via ELISA alongside routine inflammatory and immunological markers.",{"label":23,"type":13,"description":24,"interventionNames":13},"Inactive SLE Controls","Consists of 45 age- and sex-matched patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria, presenting with inactive disease (clinical remission) based on SLEDAI-2K scoring. Serum samples are collected to evaluate baseline circulating MPO-DNA complex levels and routine laboratory parameters for comparative analysis.",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Amira Khalid Ahmed Othman","Resident of Clinical pathology","100654927","serum-mpo-dna-complexes-as-a-biomarker-of-disease-activity-in-systemic-lupus-erythematosus-100654927",false,"NCT07805863","Serum MPO-DNA Complexes as a Biomarker of Disease Activity in Systemic Lupus Erythematosus","Serum Myeloperoxidase-DNA Complexes as a Novel Biomarker of Neutrophil Extracellular Trap and Disease Activity in Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria.\n* Age older than 16 years.\n* Provision of written informed consent prior to study enrollment.\n\nExclusion Criteria:\n\n* Age 16 years or younger.\n* Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).\n* Concurrent active severe infections.\n* Malignancy.\n* Pregnancy.","ALL","16 Years",{"count":39,"type":40},90,"ESTIMATED","OBSERVATIONAL","Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by immune system dysregulation and inflammation affecting multiple organs. A key mechanism in its development involves the excessive formation and impaired clearance of neutrophil extracellular traps (NETs), which release myeloperoxidase-DNA (MPO-DNA) complexes into the circulation. Although standard laboratory markers like complement proteins (C3, C4) and anti-dsDNA antibodies are routinely used, they often show inconsistent sensitivity in monitoring disease activity and flare-ups.\n\nThe primary purpose of this observational study is to evaluate serum MPO-DNA complexes as a circulating biomarker of NET formation in patients with systemic lupus erythematosus.\n\nThe study aims to:\n\n* Measure serum MPO-DNA complex levels in active SLE patients compared to age- and sex-matched inactive SLE controls.\n* Assess the correlation between MPO-DNA complex levels and clinical disease activity measured by the SLE Disease Activity Index 2000 (SLEDAI-2K) score.\n* Evaluate the diagnostic accuracy of MPO-DNA complexes compared to conventional inflammatory and immunological markers (ESR, CRP, C3, C4, and anti-dsDNA).\n\nParticipants will undergo routine clinical assessments and standard blood sampling to measure routine laboratory parameters and circulating MPO-DNA complex levels via enzyme-linked immunosorbent assay (ELISA).",[44,45],"Systemic Lupus Erythematosus","Lupus Nephritis",[47,48,49,50,51,52],"Neutrophil Extracellular Traps","Myeloperoxidase-DNA Complex","NETosis","SLEDAI-2K","Disease Activity Biomarkers","Anti-dsDNA","NOT_YET_RECRUITING","2026-09-01",{"date":56,"type":57},"2026-09-08","ACTUAL",{"date":59,"type":40},"2026-10",{"date":61,"type":40},"2027-11",{"name":5,"class":6}]