Assessment of Blood Indices in Systemic Lupus Erythematosus

NCT06872086 | Not Yet Recruiting

• 1 other identifier: blood indices in SLE
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SLE; Blood Indices

Keywords

SLE; Systemic Lupus Erythematosus; Blood Indices

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the internal medicine department

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: May 1, 2025
• Primary Completion: August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share