miR-101-3p and Autotaxin in SLE Patients

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07252141

Enrollment

Registered

2025-11-26

Start date

2025-12-30

Completion date

2026-07-30

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Serum levels of miR-101-3p and Autotaxin in SLE patients versus healthy controls	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

Measure	Time frame	Description
Correlation between miR-101-3p and Autotaxin levels	6 monthes expected	To evaluate the relationship between serum miR-101-3p and Autotaxin concentrations in SLE patients.

Outcome results