miR-101-3p and Autotaxin in SLE Patients

NCT ID: NCT07252141

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-07-30

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eman Mohamed Shawky

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohamed Shawky

Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine, Assiut University

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

IRB.no: 04-2025-300546

Identifier Type: -

Identifier Source: org_study_id