SLENCT06872086
Assessment of Blood Indices in Systemic Lupus Erythematosus
An observational study of SLE and Blood Indices, run by Assiut University.
Trial summary
This case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- SLE, Blood Indices
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: cases are Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR/EULAR classification criteria and • Healthy controls without any autoimmune diseases or significant comorbidities
Who may be able to join
- Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR/EULAR classification criteria.
- Healthy controls without any autoimmune diseases or significant comorbidities
Who cannot join
- • Patients with other autoimmune diseases (e.g., rheumatoid arthritis, Sjögren's syndrome).
- Recent infections or acute inflammatory conditions.
- Individuals with hematological disorders unrelated to SLE (e.g., leukemia, lymphoma).
About this study
Official title: Assessment of Blood Indices As Predictors of Disease Activity in Systemic Lupus Erythematosus
This case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE).
The study includes 70 SLE patients and 70 healthy controls, matched for age and gender, recruited from Assiut University Hospital.
Disease activity is assessed using the SLEDAI-2K score, and blood indices are analyzed to determine correlations with disease activity.
Read the detailed description
This case-control study will be conducted at Assiut University Hospital, involving 70 patients diagnosed with SLE according to the 2019 ACR/EULAR classification criteria and 70 healthy controls matched for age and gender. Inclusion criteria include patients aged 18 years or older with SLE, while exclusion criteria include other autoimmune diseases, recent infections, and hematological disorders unrelated to SLE.
Study Tools and Procedures:
Demographic Information: Collect data on age, gender, duration of illness, and relevant medical history.
Clinical Assessment: Disease activity will be evaluated using the SLEDAI-2K score, which includes parameters such as mucocutaneous manifestations, musculoskeletal symptoms, renal involvement, neurological symptoms, and hematological abnormalities.
Laboratory Tests: A complete blood count (CBC) will be performed to obtain lymphocyte, monocyte, neutrophil, and platelet counts. Additional tests may include serum creatinine levels, urinalysis for proteinuria, 24-hour urinary proteins, CRP, ESR, and complement levels (C3, C4) to assess overall disease status.
Study Tools: The SLEDAI-2K tool will categorize patients based on their disease activity levels. CBC results will be analyzed to calculate LMR, NLR, PLR, and SIRI, which will be correlated with the SLEDAI-2K score.
Research Outcome Measures Primary Outcome: The primary objective is to assess the correlation between blood indices (LMR, NLR, PLR, SIRI) and SLE disease activity as measured by the SLEDAI-2K score. This will involve statistical analysis to determine if there is a significant correlation between these indices and disease activity.
Secondary Outcomes:
Comparison of Blood Indices: Evaluate differences in LMR, NLR, PLR, and SIRI between SLE patients and healthy controls.
Disease Activity Variability: Analyze how variations in blood indices correlate with changes in SLEDAI-2K scores over time.
Exploration of Additional Hematological Indices: Investigate other hematological parameters such as mean platelet volume (MPV) to determine their association with disease activity.
Impact of Treatment: Assess how treatment interventions affect blood indices and correlate these changes with improvements or deteriorations in SLEDAI-2K scores.
- Conditions
- SLE, Blood Indices
- Keywords
- SLE, Systemic Lupus Erythematosus, Blood Indices
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| SLE Patients | This group consists of 70 adult patients diagnosed with systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria. These participants will undergo clinical assessments to evaluate disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Blood indices, including lymphocyte-monocyte ratio (LMR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammatory index (SIRI), will be analyzed to investigate their correlation with disease activity. | |
| Healthy Controls | This group includes 70 age- and gender-matched healthy individuals without autoimmune diseases or significant comorbidities. Participants will serve as controls for comparison of blood indices, including LMR, NLR, PLR, and SIRI, to establish baseline values and assess differences between healthy individuals and SLE patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Blood Indices and SLEDAI -2K score
The primary outcome of this study will be to assess the relationship between lymphocyte-monocyte ratios (LMR), neutrophil-to-lymphocyte ratios (NLR), platelet-to-lymphocyte ratios (PLR), systemic immune-inflammatory index (SIRI) and systemic lupus erythematosus disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). This will involve statistical analysis to determine if there is a significant correlation between these blood indices and the SLEDAI-2K score, indicating their potential utility as biomarkers for SLE activity.
Measured: 1 month
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 May 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ibrahim Altayeb Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872086
- Sponsor's protocol ID
- blood indices in SLE
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Indices As Predictors of Disease Activity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06872086
- Acronym / sponsor ID
- blood indices in SLE
- Conditions
- SLE, Blood Indices
- Keywords
- SLE, Systemic Lupus Erythematosus, Blood Indices
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- 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 case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE).
The study includes 70 SLE patients and 70 healthy controls, matched for age and gender, recruited from Assiut University Hospital.
Disease activity is assessed using the SLEDAI-2K score, and blood indices are analyzed to determine correlations with disease activity.
Detailed description
This case-control study will be conducted at Assiut University Hospital, involving 70 patients diagnosed with SLE according to the 2019 ACR/EULAR classification criteria and 70 healthy controls matched for age and gender. Inclusion criteria include patients aged 18 years or older with SLE, while exclusion criteria include other autoimmune diseases, recent infections, and hematological disorders unrelated to SLE.
Study Tools and Procedures:
Demographic Information: Collect data on age, gender, duration of illness, and relevant medical history.
Clinical Assessment: Disease activity will be evaluated using the SLEDAI-2K score, which includes parameters such as mucocutaneous manifestations, musculoskeletal symptoms, renal involvement, neurological symptoms, and hematological abnormalities.
Laboratory Tests: A complete blood count (CBC) will be performed to obtain lymphocyte, monocyte, neutrophil, and platelet counts. Additional tests may include serum creatinine levels, urinalysis for proteinuria, 24-hour urinary proteins, CRP, ESR, and complement levels (C3, C4) to assess overall disease status.
Study Tools: The SLEDAI-2K tool will categorize patients based on their disease activity levels. CBC results will be analyzed to calculate LMR, NLR, PLR, and SIRI, which will be correlated with the SLEDAI-2K score.
Research Outcome Measures Primary Outcome: The primary objective is to assess the correlation between blood indices (LMR, NLR, PLR, SIRI) and SLE disease activity as measured by the SLEDAI-2K score. This will involve statistical analysis to determine if there is a significant correlation between these indices and disease activity.
Secondary Outcomes:
Comparison of Blood Indices: Evaluate differences in LMR, NLR, PLR, and SIRI between SLE patients and healthy controls.
Disease Activity Variability: Analyze how variations in blood indices correlate with changes in SLEDAI-2K scores over time.
Exploration of Additional Hematological Indices: Investigate other hematological parameters such as mean platelet volume (MPV) to determine their association with disease activity.
Impact of Treatment: Assess how treatment interventions affect blood indices and correlate these changes with improvements or deteriorations in SLEDAI-2K scores.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE Patients | – | –This group consists of 70 adult patients diagnosed with systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR classification criteria. These participants will undergo clinical assessments to evaluate disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). Blood indices, including lymphocyte-monocyte ratio (LMR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammatory index (SIRI), will be analyzed to investigate their correlation with disease activity. |
| Healthy Controls | – | –This group includes 70 age- and gender-matched healthy individuals without autoimmune diseases or significant comorbidities. Participants will serve as controls for comparison of blood indices, including LMR, NLR, PLR, and SIRI, to establish baseline values and assess differences between healthy individuals and SLE patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cases are Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR/EULAR classification criteria and • Healthy controls without any autoimmune diseases or significant comorbidities
Key inclusion criteria (2 listed)
- Patients aged 18 years or older diagnosed with SLE according to the 2019 ACR/EULAR classification criteria.
- Healthy controls without any autoimmune diseases or significant comorbidities
Key exclusion criteria (3 listed)
- • Patients with other autoimmune diseases (e.g., rheumatoid arthritis, Sjögren's syndrome).
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
Correlation between Blood Indices and SLEDAI -2K score
Time frame: 1 month
The primary outcome of this study will be to assess the relationship between lymphocyte-monocyte ratios (LMR), neutrophil-to-lymphocyte ratios (NLR), platelet-to-lymphocyte ratios (PLR), systemic immune-inflammatory index (SIRI) and systemic lupus erythematosus disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). This will involve statistical analysis to determine if there is a significant correlation between these blood indices and the SLEDAI-2K score, indicating their potential utility as biomarkers for SLE activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE and Blood Indices, run by Assiut University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between Blood Indices and SLEDAI -2K score (time frame: 1 month). 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 12 Mar 2025.