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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05468866

Enrollment

100

Registered

2022-07-21

Start date

2022-09-01

Completion date

2023-03-01

Last updated

2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Brief 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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 65 Years

Healthy volunteers

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

* 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) .

Design outcomes

Primary

Measure	Time frame	Description
rs1980422-related single-nucleotide polymorphisms	6 months	Genotyping of rs1980422-related single-nucleotide polymorphisms by real time PCR.

Countries

Egypt

Contacts

Primary ContactBedor E Hussien, assistant lecture

bodor.badr@med.sohag.edu.eg01066072377

Backup ContactAhmed A Allam, assistant professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026