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Not yet recruitingNCT07014904ITPUpdated Jun 17, 2025

"Cytotoxic T Lymphocyte-Associated Antigen-4 (CTLA-4) Gene Single-nucleotide Polymorphism in Primary Immune Thrombocytopenic Purpura in Children"

An observational study in ITP - Immune Thrombocytopenia, sponsored by Sohag University. Not yet recruiting. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
80
Ages
1 Year to 18 Years
Sex
All
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Study summary

the investigators aim in this study to investigate the potential association of single gene polymorphisms of CTLA-4 (SNPs; rs: 3087243) using real-time PCR in children with primary ITP.

Read the detailed description

Primary immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder characterized by isolated thrombocytopenia (platelet count \< 100 × 109/L) in the absence of other etiologies. The incidence of the disease is approximately 2-10 per 100,000 adults each year, with a prevalence of 9-20 per 100,000 adults Auto antibody-mediated platelet destruction is the canonical mechanism of platelet destruction in ITP. Platelets coated by anti-glycoprotein (GP) autoantibodies are prematurely destroyed by macrophages via Fcγ receptors (FcγRs) in the reticuloendothelial system. Autoantibodies also accelerate platelet destruction through the induction of complement-dependent cytotoxicity (CDC) and platelet apoptosis Many studies have demonstrated that CD8+ cytotoxic T lymphocytes (CTLs) from peripheral blood or spleen of ITP patients can directly lyse platelets or induce platelet apoptosis through granzyme B and perforin. CTLs and anti-GP autoantibodies can induce the desialylation of platelet surface glycans, leading to premature platelet clearance.

The immune checkpoint pathways are critical modulators of the immune system, allowing immune response initiation and preventing autoimmunity onset. Immune checkpoints, including co-stimulation and co-inhibition signal pathways, are among the central mechanisms that regulate T-cell-mediated immune responses CTLA-4 production is strongly influenced by genetic factors. Single-nucleotide polymorphisms (SNPs) of the CTLA-4-encoding genes are involved in the pathogenesis of many autoimmune diseases such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) In recent years, it had been shown that thrombocytopenia was associated with the transcription level of CTLA4 and regulation of T-cell activation

02

Conditions studied

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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 80 is below the median of 120 across 183 observational 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 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  1. Full history taking.
  2. Through clinical examination.
  3. Laboratory investigations:

a .Complete blood count with platelet indices: Mean Platelet Volume, Plateletcrit, platelet distribution width (MPV, PCT \& PDW).

b. Genotyping of rs3087243-related single-nucleotide polymorphism.

Eligibility criteria

Inclusion criteria: approval to sign an informed written consent, patient with newly diagnosed ITP, patient age > 1 year and \< 18 years and both sexes are included.

Exclusion criteria:

Refusal to sign an informed written consent, patient with persistent ITP, patient with chronic ITP, patient with secondary immune thrombocytopenia and patient age \< 1 year or > 18 years

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • investigate the potential association of single gene polymorphisms of CTLA-4 (SNPs; rs: 3087243) usi
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What researchers measure

Primary outcomes

  1. investigate the potential association of single gene polymorphisms of CTLA-4 (SNPs; rs: 3087243) using real-time PCR in children with primary ITP.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, 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
NCT07014904
Lead sponsor
Sohag University
Responsible party
Reham Elsayed Mohamed (Principal Investigator, Sohag University) — Principal investigator
First posted
Jun 11, 2025
Start date
Aug 20, 2025 (estimated)
Primary completion
Jun 4, 2027 (estimated)
Completion
Jul 20, 2027 (estimated)
Last update
Jun 17, 2025

Study contacts

Reham Elsayed Mohamed Ail Reham Elsayed Mohamed Ail, MD
Contact
Remohelmy1992@gmail.com
01013757753
Douaa Mohammed Sayed Douaa Mohammed Sayed, Prof.Dr
Contact
01006261987

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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