Assessment of Blood Indices in Systemic Lupus Erythematosus

Assiut University

Status: Not yet enrolling

Conditions: Blood Indices; SLE

Study type: Observational

Funder types: Other

Identifiers

NCT06872086

blood indices in SLE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

70 participants in 2 patient groups

SLE Patients

Description:

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

Description:

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.