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 volunteersQualifiers
• 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
Case-control
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
Trial outcomes
Primary outcomes
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)
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)
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)
Locations
Sponsors and contacts
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