An observational study in Systemic Lupus Erythematosus Nephritis and Systemic Lupus Erthematosus (SLE), sponsored by Egyptian Chinese University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Egyptian Chinese University · Observational
Lupus nephritis (LN) is a major cause of renal morbidity in systemic lupus erythematosus (SLE). Conventional clinical, renal, and serological parameters may not fully distinguish patients with renal involvement from those with SLE without LN. This cross-sectional observational study aims to evaluate a predefined panel of eight molecular biomarkers and determine their ability to discriminate between patients with established SLE with and without LN. The panel includes the non-coding RNA markers MALAT1, GAS5, miR-155, and miR-223; the inflammatory biomarkers interferon-beta (IFN-β), lipocalin-2 (LCN2), and interleukin-23 (IL-23); and the tissue-remodeling biomarker matrix metalloproteinase-9 (MMP-9). The study will also assess associations between these biomarkers and conventional clinical and laboratory parameters, disease activity, cumulative organ damage, and available renal histopathological findings. The discriminatory performance of conventional clinical assessment, the molecular biomarker panel, and their integrated combination will be evaluated.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 77 observational studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Egyptian Chinese University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with an established diagnosis of SLE attending or receiving care at the participating center(s) were considered for inclusion. Eligible participants were classified into two groups according to the presence or absence of clinically established LN: SLE+LN group; patients with SLE and LN and SLE Group; patients with SLE without LN.
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.
SLE with established lupus nephritis (LN). SLE without evidence of lupus nephritis.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with established systemic lupus erythematosus and established lupus nephritis.
Diagnostic Test: predefined molecular biomarker panel
Patients with established systemic lupus erythematosus without lupus nephritis.
Diagnostic Test: predefined molecular biomarker panel
Non-coding RNA biomarkers Expression levels of metastasis-associated lung adenocarcinoma transcript 1 (MALAT1), growth arrest-specific 5 (GAS5), microRNA-155 (miR-155), and microRNA-223 (miR-223) were assessed using quantitative reverse-transcription polymerase chain reaction (qRT-PCR). The immune-inflammatory and tissue-remodeling biomarkers IFN-β, LCN2, IL-23, and MMP-9 were assessed using enzyme-linked immunosorbent assay (ELISA). Renal histopathological information was obtained from available kidney biopsy reports and records.
Discriminatory performance of the predefined molecular biomarker panel for distinguishing SLE patients with established LN from those without LN
Evaluated using receiver operating characteristic (ROC) analysis and the area under the ROC curve (AUC).
Time frame: baseline at day 1
Associations between individual biomarkers and conventional clinical, renal, and immunological parameters, including serum creatinine, urinary protein excretion, C3, C4, and anti-dsDNA.
Time frame: baseline at day 1
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Egyptian Chinese University