Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05105217
• Other study ID #: Slit2 in SLE & SSC
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Eman Safwat
• Phone: 01014116158
• Email: safwateman605[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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. .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Lupus Erythematosus

Intervention

Other:
• Slit2 biomarker
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure the level of slit2 by ELISA in SLE patients	determining level of Slit2 in patients with SLE and define its correlation with disease activity	baseline
Secondary	measure the level of slit2 by ELISA in SSC patients	determining level of Slit2 in patients with SSC and define its correlation with disease activity	baseline

External Links

•   A review of advances in the understanding of lupus nephritis pathogenesis as a basis for emerging therapies [version 1; peer review: 2 approved]
•   Slit2 is a potential biomarker for renal impairment in systemic lupus erythematosus