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Not yet recruitingNCT07805863Updated Sep 8, 2026

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

An observational study in Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Primary conditionLupus NephritisRegistry: Lupus Erythematosus, SystemicReclassifiedWhy we changed it
Registry
Lupus Erythematosus, Systemic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lupus Nephritis
Why
  1. The study's listed conditions name Lupus Nephritis, a narrower term within Lupus Erythematosus, Systemic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Lupus Nephritis by Assiut University — 17 open to participants now, 17 under way, none of them phase 3. Lupus Nephritis · Assiut University.

Planned enrollment
12th of 21
90 · median 96
Started
2026
with 7 others
Observational
21 of 22
17 open now
Primary completion
2027-10
later than 14 of 16 live
Registered
21st of 22
by date

Among the 22 studies in Lupus Nephritis by Assiut University, this one is the 12th largest by planned enrollment of the 21 observational ones that give a count, is one of 8 that started in 2026, is one of 21 observational ones, reaches primary completion later than 14 of the 16 other live ones, and was the 21st registered.

Lupus Nephritis

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

Browse Lupus Nephritis studies →

Open to participants now

17 of the 22 studies in Lupus Nephritis by Assiut University are open now, in 1 country. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

All 17 open studies →

Where they have run

Who these studies take

Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.

This study: 16 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Lupus Nephritis by Assiut University, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Systemic Lupus Erythematosus
  • Lupus Nephritis

Browse trials for

Keywords

  • Neutrophil Extracellular Traps
  • Myeloperoxidase-DNA Complex
  • NETosis
  • SLEDAI-2K
  • Disease Activity Biomarkers
  • Anti-dsDNA
04

In context

Lupus Nephritis Reclassified

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 77 observational studies indexed under Lupus Nephritis.

Browse Lupus Nephritis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

  • Age 16 years or younger.
  • Overlapping diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
  • Concurrent active severe infections.
  • .
  • Pregnancy.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

07

What researchers measure

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: Baseline

08

Study locations

No study locations are listed for this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 8, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Nov 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07805863
Lead sponsor
Assiut University
Responsible party
Amira Khalid Ahmed Othman (Resident of Clinical pathology, Assiut University) — Principal investigator
First posted
Sep 8, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 8, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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