Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients

October 1, 2023 updated by: Mariam Mohamed Abd-Elrazik Ahmed, Assiut University

Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.

  • 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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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 .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
controls
healthy controls
patients
SLE patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum ATX level in SLE patients in comparison to healthy controls.
Time Frame: 2 years
Measure ATX level in serum of sle patients and compare it with ATX level in serum of healthy controls.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autotaxin in sle

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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