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Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder

NCT06289283 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2024-03-01

No results posted yet for this study

Summary

Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer.

Conditions

  • Urinary Bladder Neoplasms
  • Microtia

Interventions

OTHER

Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera

Samples for microbiome analysis: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigerator until be analyzed at the microbiology laboratory of TBRI. Urine samples (50 ml) for microbiome analysis will be collected during cystoscopy examination. Samples will be stored at -80 °C until processing. Tissue and urine samples from patients with bladder cancer: Under standard procedure of diagnostic cystoscopy urine sample will be collected under complete aseptic conditions, patients who has bladder tumor will undergo transurethral resection of bladder tumor, a tissue sample 0.5x0.5 cm will be investigated for microbiome analysis. Samples will be stored at -80 °C until processing. Histopathological diagnosis with Hematoxylin and eosin stain will be done by an expert pathologist for tumor grade and stage according to WHO 22, and EAU guidelines 2023. This procedure will be applied for

Sponsors & Collaborators

  • Theodor Bilharz Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289283 on ClinicalTrials.gov