S100A8NCT06872138
S100A8 in Serum and Urine as a New Biomarker in Lupus Nephritis
An observational study of S100A8 and Serum, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
This study aims to evaluate both serum and urine S100A8 as potential biomarkers for Lupus nephritis (LN) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were stratified into two main groups: Group I consisted of 50 SLE patients, further subdivided into Group IA (n=30) with LN and Group IB (n=20) without LN. Group II comprised 20 age- and sex-matched healthy controls.
Who may be able to join
- 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.
Who cannot join
- Autoimmune diseases.
- Sjogren's syndrome.
- Rheumatoid arthritis.
- Systemic sclerosis.
- Taking other biologic disease-modifying anti-rheumatic drugs.
- Immunosuppressive drugs.
- Corticosteroid.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate both serum and urine S100A8 as potential biomarkers for Lupus nephritis (LN)
Read the 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.
- Medical subject headings
- Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Control Group | Age and sex matched healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of S100A8 levels in serum for diagnosing lupus nephritis (LN)
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.
Measured: 3 months
Secondary outcomes (3)
Accessment S100A8 levels in urine for diagnosing lupus nephritis (LN)
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.
Measured: 3 months
Correlation between S100A8 level and disease activity markers
Correlation between S100A8 level and disease activity markers in patients with systemic lupus erythematosus will be measured
Measured: 3 months
Using S100A8 as a predictor for renal affection in systemic lupus erythematosus (SLE) patients for follow up and early treatment.
Renal involvement lupus Nephritis can be diagnosed by presence of proteinurea or elevated kidney function and can be confirmed by biopsy if present.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Nov 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S100A8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Khalifa Sayed, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872138
- Sponsor's protocol ID
- PT(882)
- Status last verified
- May 2025
- First submitted
- 6 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100A8 in Serum and Urine as a New Biomarker in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06872138
- Acronym / sponsor ID
- PT(882)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Control Group | – | –Age and sex matched healthy control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were stratified into two main groups: Group I consisted of 50 SLE patients, further subdivided into Group IA (n=30) with LN and Group IB (n=20) without LN. Group II comprised 20 age- and sex-matched healthy controls.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Autoimmune diseases.
- Sjogren's syndrome.
- Rheumatoid arthritis.
- Systemic sclerosis.
- Taking other biologic disease-modifying anti-rheumatic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Accessment S100A8 levels in urine for diagnosing lupus nephritis (LN)
Time frame: 3 months
Correlation between S100A8 level and disease activity markers
Time frame: 3 months
Using S100A8 as a predictor for renal affection in systemic lupus erythematosus (SLE) patients for follow up and early treatment.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for S100A8
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus
Systemic Lupus Erythematosus, Gastrointestinal Diseases
Not yet recruiting
The Effects of a Modified Mediterranean Diet on Ulcerative Colitis Patients
Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of S100A8 and Serum, run by Theodor Bilharz Research Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of S100A8 levels in serum for diagnosing lupus nephritis (LN) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.