Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT05105217
• Lead Sponsor: Assiut University

Brief Summary

1.Assessment of slit2 level in SLE patients and its correlation with disease activity.

2-Assessment of slit2 level in SSC patients and its correlation with disease activity

Detailed Description

Systemic lupus erythematosus (SLE) is the most serologically and clinically diverse autoimmune disease. Immune dysregulation leads to excess production of autoantibodies and immune complexes. excess complement activation, and insidious tissue inflammation in patients with SLE.

SLE is characterized by multisystem involvement commonly affecting the skin, renal, and musculoskeletal systems .

Lupus nephritis is an important cause of both acute kidney injury and chronic kidney disease that can result in end-stage renal disease. Its pathogenic mechanisms are characterized by aberrant activation of both innate and adaptive immune responses, dysregulation of inflammatory signaling pathways, and increased cytokines production .

Systemic sclerosis (SSC) is an autoimmune disease with characteristic vascular damage and fibrosis of the skin and internal organs. Diagnosis of SSC is mainly based on the clinical course and features in addition to laboratory findings including autoantibody profiles

. Slit2, as a member of the Slit family, is secreted glycoprotein. Slit2 functions by binding to its transmembrane receptor Robo. Robo has four isoforms (Robo14). Slit2-Robo regulates cell functions, such as regulating leukocytes in chemotaxis and promoting endothelial cell migration and tube formation.

Slit2 might promote the pathogenesis of LN by affecting various cell dysfunction in addition to leukocyte infiltration.

In SSC, vascular involvement is a primary event characterized by vascular tone dysfunction and microcirculatory abnormalities. Many classes of guidance molecules, such as members of the secreted glycoproteins Slits and their Roundabout (Robo) receptors, play critical roles in angiogenesis. Among these, Robo1 and Robo4 are expressed in endothelial cells. .

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Study Start: 2021-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Adult SLE Patients who fulfilled the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus .
2. Adult SSC patients who fulfilled the 2013 EULAR / ACR for SSC

Exclusion Criteria

• Individuals with other autoimmune diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measure the level of slit2 by ELISA in SLE patients	baseline	determining level of Slit2 in patients with SLE and define its correlation with disease activity

Secondary Outcome Measures

Name	Time	Method
measure the level of slit2 by ELISA in SSC patients	baseline	determining level of Slit2 in patients with SSC and define its correlation with disease activity