Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients

Not yet recruiting

• Conditions: SLE (Systemic Lupus)

• Registration Number: NCT06063668
• Lead Sponsor: Assiut University

Brief Summary

* Estimation of the serum ATX level in SLE patients in comparison to healthy subjects.

* Evaluation of the relation of serum ATX level with disease activity and different clinical manifestation in SLE patients

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune inflammatory disease with unknown etiology . However, several genetic, immunological and environmental factors play a role in the etiopathogenesis of SLE . During the disease course, patients may be presented with diverse clinical manifestations (mucocutaneous, articular, neurological, or renal manifestations) . Anti-nuclear antibodies(ANA), anti- double stranded DNA (ds-DNA)and anti smith(SM) antibodies are common biomarkers of SLE. However the sensitivity and specificity of the current biomarkers are not ideal that the diagnosis of SLE can be missed .

Lysophospholipids are phospholipids with only one fatty acid chain, such as lysophosphatidic acid (LPA) and lysophosphatidylserine. Autotaxin (ATX), one of the enzymes that catalyze the formation of Lysophospholipid, is mainly responsible for the production of LPA in blood . Tumor necrosis factor (TNF), interleukin-6 (IL-6), and type I interferons, have been reported to induce the expression of ATX . ATX was reported recently as potential biomarkers of various diseases (serum ATX in malignancy and chronic hepatitis C, while in acute myocardial infarction ATX was overexpressed in cardiac tissue and in the synovium of rheumatoid arthritis patients) . Several studies have reported that serum ATX concentrations were higher in females than in males . The mRNA expression of ATX was found to be significantly induced by estrogen . There is growing evidence that ATX may play a role in the pathogenesis of SLE. Few recent studies have reported that serum ATX level can be a possible novel biomarker and key molecule in SLE .

Study Timeline

• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Status Verified: 2023-10
• Study Start: 2023-10
• Last Update Submitted: 2023-10-01
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patients who will be diagnosed as SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
• SLE Patients older than 18 years old.

Exclusion Criteria

• SLE Patients younger than 18 years old.
• Patients with other rheumatic diseases or overlap syndromes.
• Patients with malignancy.
• Patients with chronic hepatitis C.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ATX level in SLE patients in comparison to healthy controls.	2 years	Measure ATX level in serum of sle patients and compare it with ATX level in serum of healthy controls.