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Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06063668
Collaborator
(none)
94
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    94 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    SLE patients
    controls

    healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Nada Mohamed Gamal Abd-Elaleem, Ass. Prof, Assiut University
    • Study Chair: Maha Sayed Ibrahim Abdelrahman, Lecturer, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariam Mohamed Abd-Elrazik Ahmed, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06063668
    Other Study ID Numbers:
    • Autotaxin in sle
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 3, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Oct 3, 2023