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NCT05585944 Clinical Trial

" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "

Immune Thrombocytopenic Purpura Clinical Trial

Official title:
" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05585944
Other study ID # Soh-Med-22-10-21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date May 1, 2023

Study information
Verified date October 2022
Source Sohag University
Contact nagwa M Aboelmahasen, assisstant lecturer
Phone 01008831102
Email nagwa.abdelaty@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immune thrombocytopenia is an acquired autoimmune disease, in which platelets are opsonized by auto-antibodies and destroyed by phagocytic cells .Genetic polymorphisms in the immune mediators have been suggested to play a pivotal role in the pathogenesis of many autoimmune disorders . Several genetic polymorphisms of the immune system genes have been described in ITP such as interleukins, tumor necrosis factors (TNF) alpha and beta, and interferon-gamma., These polymorphisms were found to be associated with an increased risk of ITP progression or exacerbation .CD40 is a co-stimulatory 4348 kDa glycoprotein molecule composed of 277 amino acid residues which belongs to the tumor necrosis family. It is encoded by a gene which is located at chromosome 20q11-13, expressed mainly on antigen presenting cells (APCs), some non-immune cells and tumors.Antinuclear antibodies (ANA) is a collective term for a large and heterogeneous group of circulating autoantibody. Reflecting their clinical importance, ANA are diagnostic, prognostic or classification criteria for many autoimmune diseases.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 65 Years
Eligibility Inclusion Criteria: - sign an informed written consent from the patients or their parents - patient with newly diagnosed ITP - patient age > 1 year and < 65 years and both sexes are included. Exclusion Criteria: - Refusal to sign an informed written consent - patient with persistent ITP, patient with secondary immune thrombocytopenia - patient age < 1 year or > 65 years.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Genotyping of rs1883832C/T related single-nucleotide polymorphism
Genotyping of rs1883832C/T related single-nucleotide polymorphism by real time pcr

Locations
Country Name City State
Egypt Sohag University hospitals Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Behzad MM, Asnafi AA, Jalalifar MA, Moghtadaei M, Jaseb K, Saki N. Cellular expression of CD markers in immune thrombocytopenic purpura: implications for prognosis. APMIS. 2018 Jun;126(6):523-532. doi: 10.1111/apm.12853. — View Citation

Chen JM, Guo J, Wei CD, Wang CF, Luo HC, Wei YS, Lan Y. The association of CD40 polymorphisms with CD40 serum levels and risk of systemic lupus erythematosus. BMC Genet. 2015 Oct 16;16:121. doi: 10.1186/s12863-015-0279-8. — View Citation

Favaloro EJ. How to Generate a More Accurate Laboratory-Based International Normalized Ratio: Solutions to Obtaining or Verifying the Mean Normal Prothrombin Time and International Sensitivity Index. Semin Thromb Hemost. 2019 Feb;45(1):10-21. doi: 10.1055/s-0038-1667342. Epub 2018 Aug 22. — View Citation

Morodomi Y, Kanaji S, Won E, Ruggeri ZM, Kanaji T. Mechanisms of anti-GPIba antibody-induced thrombocytopenia in mice. Blood. 2020 Jun 18;135(25):2292-2301. doi: 10.1182/blood.2019003770. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary rs1883832C/T related single-nucleotide polymorphism effect of single-nucleotide polymorphism of CD40 gene (rs1883832 C/T) on the risk of immune thrombocytopenic purpura 6 months
Secondary ANA ANA in immune thrombocytopenic purpura 6 months
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