Systemic Lupus ErythematosusNCT07805863
Serum MPO-DNA Complexes as a Biomarker of Disease Activity in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age 16 years or younger.
- Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
- Concurrent active severe infections.
- Malignancy.
- Pregnancy.
About this study
Official title: Serum Myeloperoxidase-DNA Complexes as a Novel Biomarker of Neutrophil Extracellular Trap and Disease Activity in Systemic Lupus Erythematosus
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.
Read more
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
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Khalid Ahmed Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805863
- Sponsor's protocol ID
- MPO-DNA in Lupus Activity
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Myeloperoxidase-DNA Complexes as a Novel Biomarker of Neutrophil Extracellular Trap and Disease Activity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07805863
- Acronym / sponsor ID
- MPO-DNA in Lupus Activity
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Keywords
- Neutrophil Extracellular Traps, Myeloperoxidase-DNA Complex, NETosis, SLEDAI-2K, Disease Activity Biomarkers, Anti-dsDNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Age 16 years or younger.
- Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
- Concurrent active severe infections.
- Malignancy.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Myeloperoxidase-DNA (MPO-DNA) Complex Concentration
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Lupus Nephritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Myeloperoxidase-DNA (MPO-DNA) Complex Concentration (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.