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Status unknownNCT05468866Updated Jul 21, 2022

The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia

An interventional study of Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR in Immune Thrombocytopenia, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-21.

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

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Year to 65 Years
Sex
All
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Study summary

Primary immune thrombocytopenia (ITP), one of the most common bleeding disorders, is characterized by reduced platelet count and an increased risk of bleeding ITP is an acquired autoimmune disease, in which platelets are opsonized by auto-antibodies and destroyed by phagocytic cells ITP pathogenesis involves a hyper-activated T cell response, which is important for cell-mediated cytotoxicity and IgG production Therefore, investigating T cell abnormalities in ITP patients may reveal the mechanism of pathogenesis and development of ITP.

The costimulatory molecules of T cells consist of CD28, inducible costimulatory (ICOS), TNF superfamily member 4 (TNFSF4), and DNAM1 (CD226), and the co-inhibitory molecules contain TIM3, cytotoxic T-lymphocyte associated protein 4 (CTLA4), programmed death-1 (PD1), and lymphocyte activating 3 (LAG3) Among these, CD28 and CTLA4 represent the best-studied costimulatory pathways. CD28 and CTLA4 interact with two ligands (CD80 and CD86) on the surface of antigen-presenting cells (APCs), introducing a positive stimulatory and a negative inhibitory signal into T cells, respectively

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Conditions studied

  • Immune Thrombocytopenia
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In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 100 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia 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
No

Inclusion criteria

  • approval to sign an informed written consent
  • patient with newly diagnosed ITP
  • platelet count of peripheral blood \< 100×109/ L on at least two consecutive routine blood tests, normal or increased megakaryocyte count in bone marrow (as previously diagnosed)
  • no other disease or condition related to thrombocytopenia
  • patient age > 1 year and \< 65 years

Exclusion criteria

Exclusion Criteria:

  • Refusal to sign an informed written consent
  • Patients with other autoimmune or hemorrhagic diseases (e.g., SLE, severe anemia), or thrombocytopenia due to pregnancy, viruses (e.g., hepatitis C virus, human immunodeficiency virus)
  • active infections
  • vaccinations, or drugs (e.g., heparin) .
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Study design

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

Study arms

  • Active comparator
    group (I)

    Group (I): represents the healthy control individuals (30 person) (recruited from the blood donors at the blood bank)

    Genetic: Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR

  • Active comparator
    Group (II)

    Group (II): represents the cases of immune thrombocytopenia (70 cases).

    Genetic: Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR

Interventions

  • GeneticGenotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR

    detection of rs1980422-related single-nucleotide polymorphisms and percentage of (CD3,CD4,CD28) by immunophenotyping

    Also known as: Immunophenotyping (CD3, CD4, CD28) by flow cytometry

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What researchers measure

Primary outcomes

  1. rs1980422-related single-nucleotide polymorphisms

    Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.

    Time frame: 6 months

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Study locations

1 site
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References and documents

Publications

  • Badami E, Cexus ONF, Quaratino S. Activation-induced cell death of self-reactive regulatory T cells drives autoimmunity. Proc Natl Acad Sci U S A. 2019 Dec 26;116(52):26788-26797. doi: 10.1073/pnas.1910281116. Epub 2019 Dec 9. PubMed 31818938 ↗
  • Curdy N, Lanvin O, Laurent C, Fournie JJ, Franchini DM. Regulatory Mechanisms of Inhibitory Immune Checkpoint Receptors Expression. Trends Cell Biol. 2019 Oct;29(10):777-790. doi: 10.1016/j.tcb.2019.07.002. Epub 2019 Aug 1. PubMed 31378317 ↗
  • Ferreira RC, Castro Dopico X, Oliveira JJ, Rainbow DB, Yang JH, Trzupek D, Todd SA, McNeill M, Steri M, Orru V, Fiorillo E, Crouch DJM, Pekalski ML, Cucca F, Tree TI, Vyse TJ, Wicker LS, Todd JA. Chronic Immune Activation in Systemic Lupus Erythematosus and the Autoimmune PTPN22 Trp620 Risk Allele Drive the Expansion of FOXP3+ Regulatory T Cells and PD-1 Expression. Front Immunol. 2019 Nov 8;10:2606. doi: 10.3389/fimmu.2019.02606. eCollection 2019. PubMed 31781109 ↗
  • Huang C, Zhu HX, Yao Y, Bian ZH, Zheng YJ, Li L, Moutsopoulos HM, Gershwin ME, Lian ZX. Immune checkpoint molecules. Possible future therapeutic implications in autoimmune diseases. J Autoimmun. 2019 Nov;104:102333. doi: 10.1016/j.jaut.2019.102333. Epub 2019 Sep 26. PubMed 31564474 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 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
NCT05468866
Lead sponsor
Sohag University
Responsible party
Bedor Elsayed Hussien (Assistant lecturer of clinical and chemical pathology, Sohag University) — Principal investigator
First posted
Jul 21, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Mar 1, 2023 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Jul 21, 2022

Study contacts

Bedor E Hussien, assistant lecture
Contact
bodor.badr@med.sohag.edu.eg
01066072377
Ahmed A Allam, assistant 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 Jul 2022. You cannot join it, but the record below documents what was studied.

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