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Not yet recruitingNCT06462599Updated Jun 17, 2024

Osteopontin Gene Polymorphism in Stroke Patients in Egypt

An observational study in Ischemic Stroke, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-17.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
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Study summary

This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients

Read the detailed description

The Global Burden of Disease estimated that one person in four aged 25 years will have a stroke in the rest of her/his life. Among them, ischemic stroke (IS) represents 80%.

Stroke is accompanied by a neuroinflammatory response involving immune system. These long-term processes following IS are still far from being understood. So, despite the significant improvement in the diagnosis and treatment of IS, the disability and mortality rate of IS are still rising. An assessment of the prognostic risk of IS should be carried out as early as possible and corresponding interventions should be adopted clinically, in order to have a significant impact on the prognosis of patients with IS.

Predicting the outcome in individual patients solely based on clinical and radiological parameters is challenging for clinicians. Measuring blood biomarkers associated with inflammation, endothelial function, matrix remodeling, and immune functions, may improve prediction performance .

Osteopontin (OPN) is a matricellular protein participating in many physiological and pathologic processes including wound healing, bone turnover, tumor genesis, inflammation, and immune responses . It is well accepted that OPN is an important mediator in stroke pathophysiology. OPN expression is upregulated in microglia surrounding the infarcted area and in microglia and infiltrating macrophages in the infarct area. OPN and microglia seems to exhibit an intimate relationship in stroke with rather beneficial functions for the clinical outcome. However, the role of OPN in stroke-related diseases as atherosclerosis and diabetes should be further disentangled as in this early phase of disease OPN may ultimately culminate in cerebrovascular dysfunction. OPN may exert opposing effects and should be therefore addressed differently.

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Conditions studied

  • Ischemic Stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

we will enrol 72 participants; 36 stroke patients and 36 control cases (age matched) recruited among the attendants of Neurology department, Assiut University Hospital, adult age.

Inclusion criteria

  • For acute ischemic stroke cases:

( Acute ischemic stroke will be defined as an episode of focal neurological deficits lasting for more than 24 hour with relevant lesion in brain computerized tomography (CT) or magnetic resonance (MR) image>)

1- both sex 2- Age between 18 to 70 years old. 3-symptoms suggestive of acute ischemic stroke: presenting within 24 hours of onset of these symptoms

  • For old ischemic stroke:

    1. both sex
    2. Age between 18 to 70 years old.
    3. Duration of3to 6 month of development of ischemic symptoms
  • For control cases:

    1. both sex
    2. Healthy people
    3. Age: above 18 years old

Exclusion criteria

Exclusion Criteria:

Patients with a previous history of stroke; Patients with hemorrhagic stroke. Patients with coronary heart disease, heart failure, chronic inflammation, intracranial infection/brain tumor and malignant tumor.

Patients with liver, kidney and other important organ dysfunction. Patients with severe abnormal coagulation function

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cases

    Patients with ischaemic stroke

    Genetic: Gene polymorphism from blood samples

  • Control

    Healthy individuals

    Genetic: Gene polymorphism from blood samples

Interventions

  • GeneticGene polymorphism from blood samples

    Blood samples will be collected from stroke patients within 24 hrs of stroke and normal volunteers. Two samples will be collected serum and plasma; five ml whole blood from patients and normal volunteers and centrifuge serum samples at 1500 rpm 10 min then will be stored at - 80 °C until the day of the analysis. Plasma samples will be stored at - 80 °C until the day of the analysis without centrifugation

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What researchers measure

Primary outcomes

  1. Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease

    investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients. Correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Jing M, Li B, Hou X, Shoba J, Li C, Liang H, Zhang X, Liu E, Yang B, Meng X. OPN gene polymorphism and the serum OPN levels confer the susceptibility and prognosis of ischemic stroke in Chinese patients. Cell Physiol Biochem. 2013;32(6):1798-807. doi: 10.1159/000356613. Epub 2013 Dec 13. PubMed 24355932 ↗
  • Meseguer E, Diallo D, Labreuche J, Charles H, Delbosc S, Mangin G, Monteiro Tavares L, Caligiuri G, Nicoletti A, Amarenco P. Osteopontin Predicts Three-Month Outcome in Stroke Patients Treated by Reperfusion Therapies. J Clin Med. 2020 Dec 13;9(12):4028. doi: 10.3390/jcm9124028. PubMed 33322093 ↗
  • Zhang Y, Wang JR, Zhang EN, Zhao ZJ. Analysis of the effect of changes in serum osteopontin levels on patients with acute cerebral infarction. Pak J Med Sci. 2024 Mar-Apr;40(4):718-722. doi: 10.12669/pjms.40.4.7045. PubMed 38544995 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2024, 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
NCT06462599
Lead sponsor
Assiut University
Responsible party
Madonna Nabil (Assistant lecturer, Assiut University) — Principal investigator
First posted
Jun 17, 2024
Start date
Sep 2024 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jun 17, 2024

Study contacts

Madonna Nabil, Demonstrator
Contact
nabilmagy69@gmail.com
01285958827
Thoraya Eldeeb, Professor
Contact
thyriaeldeeb49@gmail.com
01060566244
Michel Effat, Lecturer
study director · Researcher

Oversight

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 Jun 2024. You cannot join it, but the record below documents what was studied.

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