Clinical trial NCT05585944: " Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "
Official title: " Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Thrombocytopenic Purpura
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: rs1883832C/T related single-nucleotide polymorphism
timeFrame: 6 months
Secondary outcomes:
measure: ANA
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: 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.
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.
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.
citation: Morodomi Y, Kanaji S, Won E, Ruggeri ZM, Kanaji T. Mechanisms of anti-GPIbalpha antibody-induced thrombocytopenia in mice. Blood. 2020 Jun 18;135(25):2292-2301. doi: 10.1182/blood.2019003770.