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临床试验/NCT06872138
NCT06872138已完成不适用

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

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Assessment of S100A8 levels in serum for diagnosing lupus nephritis (LN)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Accessment S100A8 levels in urine for diagnosing lupus nephritis (LN)(3 months)
  • Correlation between S100A8 level and disease activity markers(3 months)
  • Using S100A8 as a predictor for renal affection in systemic lupus erythematosus (SLE) patients for follow up and early treatment.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Khalifa Sayed

Assistant Professor of Nephrology, Theodor Bilharz Research Institute (TBRI), Giza, Egypt

Theodor Bilharz Research Institute

研究点 (1)

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