Assessment of Blood Indices in Systemic Lupus Erythematosus

March 7, 2025 updated by: Maha Ibrahim Altayeb Sayed, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • blood indices in SLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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