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Status unknownNCT05585944Updated Oct 19, 2022

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

An interventional study of Genotyping of rs1883832C/T related single-nucleotide polymorphism in Immune Thrombocytopenic Purpura, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Year to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Immune Thrombocytopenic Purpura
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In context

Purpura

263 studies on the registry are indexed under Purpura; 27 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 171 interventional studies indexed under Purpura.

Browse Purpura studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    control

    healthy participants

    Diagnostic Test: Genotyping of rs1883832C/T related single-nucleotide polymorphism

  • Active comparator
    cases

    cases of immune thrombocytopenic purpura

    Diagnostic Test: Genotyping of rs1883832C/T related single-nucleotide polymorphism

Interventions

  • Diagnostic testGenotyping of rs1883832C/T related single-nucleotide polymorphism

    Genotyping of rs1883832C/T related single-nucleotide polymorphism by real time pcr

    Also known as: ANA test.

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What researchers measure

Primary outcomes

  1. rs1883832C/T related single-nucleotide polymorphism

    effect of single-nucleotide polymorphism of CD40 gene (rs1883832 C/T) on the risk of immune thrombocytopenic purpura

    Time frame: 6 months

Secondary outcomes

  1. ANA

    ANA in immune thrombocytopenic purpura

    Time frame: 6 months

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Study locations

1 site
  • Sohag University hospitals
    Sohag, Egypt
    • Magdy M Amin, Professor · Contact
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References and documents

Publications

  • 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. PubMed 29924452 ↗
  • 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. PubMed 26474561 ↗
  • 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. PubMed 30134448 ↗
  • 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. PubMed 32157300 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05585944
Lead sponsor
Sohag University
Responsible party
Nagwa Mohamed Aboelmahasen (assisstant lecturer of clinical and chemical pathology department, Sohag university hospital, Sohag University) — Principal investigator
First posted
Oct 19, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
May 1, 2023 (estimated)
Last update
Oct 19, 2022

Study contacts

nagwa M Aboelmahasen, assisstant lecturer
Contact
nagwa.abdelaty@med.sohag.edu.eg
01008831102
Elham O Hamed, Professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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