Ireland
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Starting soon Observational

Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.

NCT05941884 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2023-10-01
Last updated
2023-07-12

Condition(s) studied

Schistosoma Haematobium

Investigational drug(s) / intervention(s)

Immunohistochemistry staining,microscopic examination of urine

Immunohistochemistry staining,: Tissue samples: * Histopathological examination: Hematoxylin and Eosin slides will be prepared and examined. * The only dependable criterion for the diagnosis of bilharzial infestation is the microscopic detection of Bilharzia ova in pathological sections. * Pathology (cystitis- cancer and its grade staging will be reported in accordance with the 2022 World Health Organization Classification of Tumors of the Urinary System (17). * To quantify levels of Nuclear factor kappa B and protein kinase c α: * Immunohistochemistry according to the manufacturer's instructions.

microscopic examination of urine: Urine samples: * Mic roscopic examination (detection of S. haematobium egg - egg counting) * Detection of HSP 70 Measurements: indirect ELISA will be used to quantify HSP concentrations in urine.

Study summary

Schistosomiasis is the second most common parasitic infection affecting humans, endemic in the Middle East, especially Egypt (1), and in 42 African countries (2).

There are 5 main species infecting humans: S. mansoni, S. haematobium, S. japonicum, S. intercalatum, and S. mekongi. S. haematobium is responsible for chronic urogenital infections that may cause serious complications (3). Urinary schistosomiasis is mostly borne in rural and agricultural communities, according to WHO (4)

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Male and female patients of different age groups known to suffer from cystitis and bladder cancer regardless results from schistosomal infection or any other causes. Exclusion Criteria: * patients with concomitant other tumours. * patients with other urinary tract infection.

Primary outcome measure(s)

  • NF-kappa-B and Protein kinase Cα — 2 years
    Association and changes of NF-kappa-B and Protein kinase Cα as diagnostic markers in chronic schistosomaiasis with or without bladder cancer
  • heat shock protein — 1 year
    Changes of heat shock protein HSP 70 as urinary biomarkers for Schistosomal bladder diseases.

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospital Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05941884 on ClinicalTrials.gov ↗ ← All trials in Egypt