Assessment of Blood Indices in Systemic Lupus Erythematosus

NCT ID: NCT06872086

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-30

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.

Conditions

SLE; Blood Indices

Study Design

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

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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).

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

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maha Ibrahim Altayeb Sayed

resident at the internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

blood indices in SLE

Identifier Type: -

Identifier Source: org_study_id