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

NCT07298733 | Not Yet Recruiting

• 1 other identifier: Soh-Med-25-10-10PD
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Immune Thrombocytopenia; System; Lupus Erythematosus

Keywords

gene expression; ITP; inflammation; autoimmune

Outcome Measures

Primary Outcomes (3)

• 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)

  January 2026 to August 2026

• 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)

  January 2026 to August 2026

• 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)

  June 2026 to august 2026

Study Arms (3)

Systemic lupus erythematosis

patients proved with SLE

Diagnostic Test: measuring gene expression

Idiopathic thrombocytopenic purpura

patients proved with ITP

Diagnostic Test: measuring gene expression

Normal controls

normal persons showing no disease matching age and gender

Diagnostic Test: measuring gene expression

Interventions

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)

Idiopathic thrombocytopenic purpura; Normal controls; Systemic lupus erythematosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• Adults (18-60 years).
• Diagnosed primary ITP
• Diagnosed SLE with thrombocytopenia

You may not qualify if:

• Patients on recent immunosuppressive therapy (\<4 weeks).
• Co-existing infections, malignancies, or other autoimmune cytopenias

Sponsors & Collaborators

• Sohag University: lead

Biospecimen

Retention: SAMPLES WITH DNA

• 5 ml venous peripheral blood collected under sterile conditions. Separation of PBMCs (peripheral blood mononuclear cells).

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Lupus Erythematosus, Systemic; Inflammation

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marwa Z elsayed, Lecturer

  faculty of Medicine Sohag university

  PRINCIPAL INVESTIGATOR

• Samar M Kamal, lecturer

  fauculty of Medicine , Sohag university

  STUDY CHAIR

Central Study Contacts

Noha S Shafik, professor

CONTACT

01067261504; nohasaber@med.sohag.edu.eg

Dina H Mohmad, lecturer

CONTACT

01119886946; dinahamada87@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share