Clinical trial NCT06063668: Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients
Official title: Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SLE (Systemic Lupus)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: SLE patients fullfilling the 2012 systemic lupus international collaborating clinics (SLICC) criteria ,older than 18 years old with no other rheumatic diseases or malignancy.

Controls are healthy controls .

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Serum ATX level in SLE patients in comparison to healthy controls.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nada Mohamed Gamal Abd-Elaleem, Ass. Prof
role: STUDY_CHAIR
affiliation: Assiut University
name: Maha Sayed Ibrahim Abdelrahman, Lecturer
role: STUDY_CHAIR
References:
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