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Completed

NCT Number: NCT06872138

S100A8 in Serum and Urine as a New Biomarker in Lupus Nephritis

This study aims to evaluate both serum and urine S100A8 as potential biomarkers for Lupus nephritis (LN)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Theodor Bilharz Research Institute

Giza, 12411, Egypt

About this study

Systemic lupus erythematosus (SLE) is a systemic autoimmune/ inflammatory disease that can affect any organ of the human body. The molecular pathophysiology of SLE remains largely unknown, but complex interactions of genetic factors, the environment, and hormones contribute to disease expression.

Clinical importance of S100 calcium-binding protein A8 protein (S100A8) as a biomarker in SLE has been well-established. During an inflammatory reaction, neutrophils produce S100A8, a Ca2+-binding protein that is part of the S100 family and is found in neutrophil extracellular traps.

In addition to its primary role as a member of the S100A8/A9 heterodimer, S100A8 accumulates in various bodily compartments and functions as a damage-associated molecular pattern molecule upon release. It is a crucial regulator of inflammation and enhances the function of innate immune cells by interacting with members of the immunoglobulin superfamily of cell surface molecules, such as toll-like receptor 4 and the receptor of advanced glycation end products.

Serum S100A8 levels are linked with disease activity, glomerulonephritis, and anti-double-stranded DNA (dsDNA) antibodies (Ab), according to increasing experimental and clinical data. healthy controls (HCs) had lower serum S100A8 levels. Considering that elevated blood S100A8 levels are also seen in several inflammatory disorders such as inflammatory bowel disease and rheumatoid arthritis, it is unclear if this elevated level is adequate to serve as a biomarker specific to SLE.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Both sexes.
  • Patients with Systemic lupus erythematosus (SLE)
  • Patients with SLE and renal affection. SLE diagnosis is based on the 1997 American College of Rheumatology (ACR) criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.

Renal involvement (lupus Nephritis) (LN) can be diagnosed by presence of proteinurea or elevated kidney function and can be confirmed by biopsy if present.

Exclusion criteria

  • Autoimmune diseases.
  • Sjogren's syndrome.
  • Rheumatoid arthritis.
  • Systemic sclerosis.
  • Taking other biologic disease-modifying anti-rheumatic drugs.
  • Immunosuppressive drugs.
  • Corticosteroid.

Treatment and study plan

Primary outcomes

  1. Assessment of S100A8 levels in serum for diagnosing lupus nephritis (LN)

    Time frame: 3 months

    Venous blood (5cm blood) and urine will be collected from patients with systemic lupus erythematosus (SLE) and healthy control, and the serum will be immediately centrifuged at 15,928 relative centrifugal force (RCF) and for 10 min. The supernatant will be collected and stored at -80°C until further analysis.

    Before the enzyme-linked immunosorbent assay (ELISA) is conducted, frozen serum samples will be thawed and then diluted 1:100 in phosphate-buffered saline. S100A8 homodimer concentrations will be measured using a commercially available ELISA kit for serum.

Secondary outcomes

  1. Accessment S100A8 levels in urine for diagnosing lupus nephritis (LN)

    Time frame: 3 months

    Venous blood (5cm blood) and urine will be collected from patients with systemic lupus erythematosus (SLE) and healthy control, and the serum will be immediately centrifuged at 15,928 relative centrifugal force (RCF) and for 10 min. The supernatant will be collected and stored at -80°C until further analysis.

    Before the enzyme-linked immunosorbent assay (ELISA) is conducted, frozen urine samples will be thawed and then diluted 1:100 in phosphate-buffered saline. S100A8 homodimer concentrations will be measured using a commercially available ELISA kit for urine.

  2. Correlation between S100A8 level and disease activity markers

    Time frame: 3 months

    Correlation between S100A8 level and disease activity markers in patients with systemic lupus erythematosus will be measured

  3. Using S100A8 as a predictor for renal affection in systemic lupus erythematosus (SLE) patients for follow up and early treatment.

    Time frame: 3 months

    Renal involvement lupus Nephritis can be diagnosed by presence of proteinurea or elevated kidney function and can be confirmed by biopsy if present.

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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