Serum MPO-DNA Complexes as a Biomarker of Disease Activity in Systemic Lupus Erythematosus

NCT07805863 | Not Yet Recruiting

• 1 other identifier: MPO-DNA in Lupus Activity
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Systemic Lupus Erythematosus; Lupus Nephritis

Keywords

Neutrophil Extracellular Traps; Myeloperoxidase-DNA Complex; NETosis; SLEDAI-2K; Disease Activity Biomarkers; Anti-dsDNA

Outcome Measures

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.

  Baseline

Study Arms (2)

Active SLE Patients

Consists of 45 patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR/ACR 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.

Inactive SLE Controls

Consists of 45 age- and sex-matched patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR/ACR 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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Age 16 years or younger.
• Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
• Concurrent active severe infections.
• Malignancy.
• Pregnancy.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Clinical pathology

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09