Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus

NCT06796569 | Recruiting

• 1 other identifier: soh-Med-25-1-2MD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus

Conditions

Systemic Lupus Erythematosus; Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

• association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus

  This study aims to investigate if there is an association between the systemic immune-inflammation index (SII) and disease activity in patients with systemic lupus erythematosus using SLEDAI(systemic lupus erythematosus disease activity index) as a valid index to compare results with

  baseline

• association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus

  This study aims to investigate the association between the systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus

  baseline

Study Arms (3)

patients diagnosed with systemic lupus and lupus nephritis

this group will include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculatedusing the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.

Diagnostic Test: systemic immune inflammatory index

patients diagnosed with systemic lupus without lupus nephritis

this group will also include 30 patients, all patients will undergo the following: For the evaluation of SLE clinical disease activity SLEDAI ( systemic upus erythematosus disease activity index)scores will be recorded The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.

Diagnostic Test: systemic immune inflammatory index

healthy control group

this group will also include 30 healthy controls , they will undergo the following: The SII (systemic immune inflammatory index) will be calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.

Diagnostic Test: systemic immune inflammatory index

Interventions

systemic immune inflammatory index DIAGNOSTIC_TEST

Systemic immune inflammatory index (SII) is a combination of three hematological parameters (platelets, neutrophils, and lymphocytes) and it is calculated using the following formula: SII = (neutrophil count × platelet count)/lymphocyte count.

healthy control group; patients diagnosed with systemic lupus and lupus nephritis; patients diagnosed with systemic lupus without lupus nephritis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients attending in rheumatology outpatient clinic, sohag university hospital

You may qualify if:

• o Older than 16 years
• In a patient with SLE, patients who fulfill the criteria of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
• In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (WHO classification, and the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification.

You may not qualify if:

• Patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin B12, folate, and iron are excluded from the study.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty

Sohag, Sohag Governorate, 1670005, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Shorouk Mohamed abdelmageed, master degree

CONTACT

02 +01099082079; Shrouk011107@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: December 2, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)