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

NCT ID: NCT06872138

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-03-30

Brief Summary

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

Detailed Description

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.

Conditions

S100A8; Serum; Urine; Biomarker; Lupus; Nephritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Systemic lupus erythematosus (SLE) Group

Systemic lupus erythematosus (SLE) patients.

Group I will be subdivided into two groups:

Group IA (n=30): SLE patients with lupus nephritis (LN) Group IB (n=20): SLE patients without LN.

No interventions assigned to this group

Control Group

Age and sex matched healthy control

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Ghada Khalifa Sayed

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Theodor Bilharz Research Institute

Giza, , Egypt

Countries

Egypt

Other Identifiers

PT(882)

Identifier Type: -

Identifier Source: org_study_id