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NCT Number: NCT07252141

miR-101-3p and Autotaxin in SLE Patients

Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting multiple organs and characterized by heterogeneous clinical manifestations. This case-control study aims to assess the association between serum expression levels of MicroRNA-101-3p and Autotaxin (ATX) in SLE patients compared with healthy controls. The hypothesis is that dysregulation of miR-101-3p and ATX contributes to SLE pathogenesis and may serve as potential non-invasive biomarkers for disease activity and prognosis.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This descriptive case-control study will enroll 40 SLE patients fulfilling the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy individuals. Demographic, clinical, and laboratory data will be collected, including disease duration, activity indices (SLEDAI-2K), and damage index (SDI). Blood samples will be taken for biochemical and molecular analyses. Serum miR-101-3p expression will be quantified by qRT-PCR, while Autotaxin and IL-6 levels will be measured by ELISA. Statistical correlations between these biomarkers and clinical variables will be evaluated. The study aims to identify diagnostic and prognostic biomarkers that may guide future therapeutic targets in SLE.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study Population: Adult patients diagnosed with systemic lupus erythematosus and healthy matched controls.

Inclusion criteria

  • - Age ≥ 18 years
  • Diagnosis of SLE according to 2012 SLICC criteria
  • Willingness to participate and provide informed consent

Exclusion criteria

Age < 18 years

  • Pregnancy or lactation
  • Active infections or malignancy
  • Co-existing autoimmune diseases
  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Serum levels of miR-101-3p and Autotaxin in SLE patients versus healthy controls

    Time frame: 6 months (expected)

    To determine the difference in serum expression levels of miR-101-3p and Autotaxin between patients with systemic lupus erythematosus (SLE) and age- and sex-matched healthy controls using qRT-PCR and ELISA.

Secondary outcomes

  1. Correlation between miR-101-3p and Autotaxin levels

    Time frame: 6 monthes expected

    To evaluate the relationship between serum miR-101-3p and Autotaxin concentrations in SLE patients.

Sponsors and collaborators

Lead sponsor

Eman Mohamed Shawky

Other

Registry information

Official study title

Association Between the Expression Levels of MicroRNA-101-3p and Autotaxin in Serum of Systemic Lupus Erythematosus Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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