Back to results" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "
Primary Purpose
Immune Thrombocytopenic Purpura
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Genotyping of rs1883832C/T related single-nucleotide polymorphism
Sponsored by
About this trial
This is an interventional diagnostic trial for Immune Thrombocytopenic Purpura
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.
Sites / Locations
- Sohag University hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
cases
Arm Description
healthy participants
cases of immune thrombocytopenic purpura
Outcomes
Primary Outcome Measures
rs1883832C/T related single-nucleotide polymorphism
effect of single-nucleotide polymorphism of CD40 gene (rs1883832 C/T) on the risk of immune thrombocytopenic purpura
Secondary Outcome Measures
ANA
ANA in immune thrombocytopenic purpura
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05585944
Brief Title
" 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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
healthy participants
Arm Title
cases
Arm Type
Active Comparator
Arm Description
cases of immune thrombocytopenic purpura
Intervention Type
Diagnostic Test
Intervention Name(s)
Genotyping of rs1883832C/T related single-nucleotide polymorphism
Other Intervention Name(s)
ANA test.
Intervention Description
Genotyping of rs1883832C/T related single-nucleotide polymorphism by real time pcr
Primary Outcome Measure Information:
Title
rs1883832C/T related single-nucleotide polymorphism
Description
effect of single-nucleotide polymorphism of CD40 gene (rs1883832 C/T) on the risk of immune thrombocytopenic purpura
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ANA
Description
ANA in immune thrombocytopenic purpura
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nagwa M Aboelmahasen, assisstant lecturer
Phone
01008831102
Email
nagwa.abdelaty@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Elham O Hamed, Professor
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29924452
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.
Results Reference
background
PubMed Identifier
26474561
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.
Results Reference
background
PubMed Identifier
30134448
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.
Results Reference
background
PubMed Identifier
32157300
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.
Results Reference
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" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "
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