The Value of Interleukin-1β and Interleukin-33 Genetic Expression in the Pathogenesis and Differentiation of Primary ITP and SLE-Related Thrombocytopenia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorSohag University

About this trial

Primary immune thrombocytopenia (ITP) is an autoimmune- mediated acquired bleeding disorder, defined as a platelet count less than 100×109/L without other causes of isolated thrombocytopenia. The etiology of ITP is complex and heterogeneous, and as no specific biomarkers are indicating its presence, ITP remains a diagnosis of exclusion. The heterogeneous nature of ITP is evident in the differences in clinical presentation and response to regular treatment among patients and the multiple mechanisms that have been forwarded to account for it, such as autoantibodies, T cell dysregulation, and impaired megakaryocytes. Except primary ITP, all forms of immune-mediated thrombocytopenia is defined as secondary ITP. Secondary ITP has several causes, including autoimmune diseases such as systemic lupus erythematosus

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Adults (18-60 years).

Diagnosed primary ITP

Diagnosed SLE with thrombocytopenia

Disqualifiers

• Patients on recent immunosuppressive therapy (<4 weeks).

Co-existing infections, malignancies, or other autoimmune cytopenias

Trial population

It's a cross sectional study that will be carried out in the period from November 2025 to November 2026. * Groups: 1. Group A: Patients with newly diagnosed or chronic primary ITP. 2. Group B: Patients with SLE-associated thrombocytopenia. 3. Group C: Healthy controls (age- and sex-matched). Inclusion Criteria: * Adults (18-60 years). * Diagnosed primary ITP * Diagnosed SLE with thrombocytopenia Exclusion Criteria: * Patients on recent immunosuppressive therapy (\<4 weeks). * Co-existing infections, malignancies, or other autoimmune cytopenias. All patients will be subjected to : Sample Collection: * 5 ml peripheral blood collected under sterile conditions. * Separation of PBMCs (peripheral blood mononuclear cells). Laboratory Methods: 1. RNA Extraction: from PBMCs. 2. cDNA Synthesis: using reverse transcriptase. 3. Gene Expression Analysis: using Quantitative Real-Time PCR (qRT-PCR)

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • measuring gene expression

    Diagnostic test

    * 5 ml peripheral blood collected under sterile conditions. * Separation of PBMCs (peripheral blood mononuclear cells). for : 1. RNA Extraction: from PBMCs. 2. cDNA Synthesis: using reverse transcriptase. 3. Gene Expression Analysis using Quantitative Real-Time PCR (qRT-PCR)

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Systemic lupus erythematosis1 intervention
Group B: Idiopathic thrombocytopenic purpura1 intervention
Group C: Normal controls1 intervention

Trial outcomes

Primary outcomes

1

1. To evaluate and compare the expression levels of IL-1β and IL-33 in patients with primary ITP and those with SLE-associated thrombocytopenia

* 5 ml peripheral blood collected under sterile conditions. * Separation of PBMCs (peripheral blood mononuclear cells). Laboratory Methods: 1. RNA Extraction: from PBMCs. 2. cDNA Synthesis: using reverse transcriptase. 3. Gene Expression Analysis: * Quantitative Real-Time PCR (qRT-PCR)

Time frame
January 2026 to August 2026
2

2. To correlate cytokine expression levels with platelet counts and disease activity scores.

* 5 ml peripheral blood collected under sterile conditions. * Separation of PBMCs (peripheral blood mononuclear cells). Laboratory Methods: 1. RNA Extraction: from PBMCs. 2. cDNA Synthesis: using reverse transcriptase. 3. Gene Expression Analysis: * Quantitative Real-Time PCR (qRT-PCR)

Time frame
January 2026 to August 2026
3

3. To assess the potential of IL-1β and IL-33 as diagnostic biomarkers for differentiating ITP from SLE-thrombocytopenia.

* 5 ml peripheral blood collected under sterile conditions. * Separation of PBMCs (peripheral blood mononuclear cells). Laboratory Methods: 1. RNA Extraction: from PBMCs. 2. cDNA Synthesis: using reverse transcriptase. 3. Gene Expression Analysis: * Quantitative Real-Time PCR (qRT-PCR)

Time frame
June 2026 to august 2026

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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