Serum MPO-DNA Complexes as a Biomarker of Disease Activity in Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAssiut University
About this trial
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.
The 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.
The study aims to:
* Measure serum MPO-DNA complex levels in active SLE patients compared to age- and sex-matched inactive SLE controls. * Assess the correlation between MPO-DNA complex levels and clinical disease activity measured by the SLE Disease Activity Index 2000 (SLEDAI-2K) score. * Evaluate the diagnostic accuracy of MPO-DNA complexes compared to conventional inflammatory and immunological markers (ESR, CRP, C3, C4, and anti-dsDNA).
Participants 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria.
Age older than 16 years.
Provision of written informed consent prior to study enrollment.
Disqualifiers
Age 16 years or younger.
Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
Concurrent active severe infections.
Malignancy.
Trial population
Adult and adolescent patients (older than 16 years) diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Active SLE Patients
Group B: Inactive SLE Controls
Trial outcomes
Primary outcomes
1
Serum Myeloperoxidase-DNA (MPO-DNA) Complex Concentration
Circulating levels of myeloperoxidase-DNA (MPO-DNA) complexes, measured in optical density (OD) units or ng/mL using an enzyme-linked immunosorbent assay (ELISA), to evaluate neutrophil extracellular trap (NET) formation and compare active versus inactive SLE patients.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: