miR-101-3p and Autotaxin in SLE Patients

NCT07252141 | Not Yet Recruiting DMC

• 1 other identifier: IRB.no: 04-2025-300546
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months (expected)

Secondary Outcomes (1)

• Correlation between miR-101-3p and Autotaxin levels

  6 monthes expected

Study Arms (1)

Forty patients diagnosed with systemic lupus erythematosus and Forty healthy control group

SLE Patients Group/Cohort Description: Forty patients diagnosed with systemic lupus erythematosus according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Clinical and laboratory data, including disease activity indices (SLEDAI-2K and SDI), will be collected. Serum samples will be analyzed for miR-101-3p expression (qRT-PCR) and Autotaxin levels (ELISA). \- Group/Cohort 2 Group/Cohort Label: Healthy Controls Group/Cohort Description: Forty age- and sex-matched healthy individuals without autoimmune, infectious, or chronic inflammatory diseases. Blood samples will be collected for serum miR-101-3p and Autotaxin assessment using the same methods applied to the patient group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 40 patients diagnosed with systemic lupus erythematosus (SLE) according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy controls. Patients will be recruited from the Rheumatology and Rehabilitation Department and Internal Medicine Department (Rheumatology Unit) at Assiut University Hospitals, Egypt.

You may qualify if:

• Study Population: Adult patients diagnosed with systemic lupus erythematosus and healthy matched controls.
• \- Age ≥ 18 years
• Diagnosis of SLE according to 2012 SLICC criteria
• Willingness to participate and provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Eman Mohamed Shawky: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11