Evaluation of Slit2 in Systemic Lupus Erythematosus and S... | NCT05105217

Studies
Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients

NCT05105217

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Nov 3, 2021Actual

Enrollment

85Estimated

Phase

Not provided

Conditions

Systemic Lupus Erythematosus

Interventions

Slit2 biomarker

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Feb 1, 2023Estimated

First Submitted Date

Oct 7, 2021

First Submission Date that Met QC Criteria

Oct 22, 2021

First Posted Date

Nov 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2021

Last Update Posted Date

Nov 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eman Safwat Mohamed, Resident doctor in Rhematology and rehabilitation department, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slit2 biomarker	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Individuals with other autoimmune diseases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Adult SLE Patients
Adult SSC patients
Adult healthy control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eman Safwat	Contact	01014116158		safwateman605@gmail.com
Naema Mohamed	Contact	01223947372		naimaaly1@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

Not provided

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

ID	Term
D008180	Lupus Erythematosus, Systemic
D012595	Scleroderma, Systemic

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases