Assessment of Blood Indices in Systemic Lupus Erythematosus

Not yet recruiting

• Conditions: SLE; Blood Indices

• Registration Number: NCT06872086
• Lead Sponsor: Assiut University

Brief 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).

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Study Start: 2025-05-01
• Primary Completion: 2026-08-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• • 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Blood Indices and SLEDAI -2K score	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.