" TREX1 Gene Mutations and Their Role in Systemic Lupus Erythematosus

ConditionSystemic Lupus Erythematosus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorSouth Valley University

About this trial

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease characterized by diverse clinical manifestations, prominently involving the skin.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult aged 18-60 years

Diagnosed as SLE per 2019 EULAR/ACR classification criteria.

Presence of at least one cutaneous manifestation (acute, subacute, or chronic).

Willing to provide written informed consent for participation and genetic testing

Disqualifiers

Overlap autoimmune syndromes (e.g., dermatomyositis, systemic sclerosis).

Systemic infection, malignancy, or pregnancy.

Use of biologic therapy or immunosuppressive pulses within one month.

Trial population

* Group A: 60 adults (18-60 years) diagnosed with SLE based on 2019 EULAR/ACR criteria, each with at least one cutaneous manifestation. * Group B: 30 age- and sex-matched healthy controls with no personal or family history of autoimmune disease and negative ANA and anti-dsDNA.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

TREX1 gene polymorphisms
Diagnostic test
To assess the prevalence of selected autoantibodies as (anti-dsDNA, anti-Sm, anti-Ro/SSA, anti-La/SSB) and TREX1 gene polymorphisms in SLE patients, and their association with clinical features and disease activity

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Group A : (Systemic Lupus Erythrematosus)1 intervention

Group B: Group B (Healthy Controls)1 intervention

Trial outcomes

Primary outcomes

Systemic Lupus Erythematosus Assessment

Assessment of disease activity in Systemic Lupus Erythematosus (SLE) using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). SLEDAI-2K as follows : 1-5 is Mild disease activity 6-10 is Moderate disease activity 11 or more is Severe disease activity

Time frame

3 Months

TREX1 gene polymorphism and SLE

Assessment the association between TREX1 gene polymorphism and systemic lupus erythematosus susceptibility

Time frame

3 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

South Valley University

Lead sponsor

Source ClinicalTrials.gov

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