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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05585944
Collaborator
(none)
80
1
2
5.9
13.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Genotyping of rs1883832C/T related single-nucleotide polymorphism
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control

healthy participants

Diagnostic Test: Genotyping of rs1883832C/T related single-nucleotide polymorphism
Genotyping of rs1883832C/T related single-nucleotide polymorphism by real time pcr
Other Names:
  • ANA test.
  • Active Comparator: cases

    cases of immune thrombocytopenic purpura

    Diagnostic Test: Genotyping of rs1883832C/T related single-nucleotide polymorphism
    Genotyping of rs1883832C/T related single-nucleotide polymorphism by real time pcr
    Other Names:
  • ANA test.
  • Outcome Measures

    Primary Outcome Measures

    1. rs1883832C/T related single-nucleotide polymorphism [6 months]

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

    Secondary Outcome Measures

    1. ANA [6 months]

      ANA in immune thrombocytopenic purpura

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 65 Years
    Sexes Eligible for Study:
    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:
    • Refusal to sign an informed written consent

    • patient with persistent ITP, patient with secondary immune thrombocytopenia

    • patient age < 1 year or > 65 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University hospitals Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nagwa Mohamed Aboelmahasen, assisstant lecturer of clinical and chemical pathology department, Sohag university hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05585944
    Other Study ID Numbers:
    • Soh-Med-22-10-21
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2022