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ACTIVE NOT RECRUITING
NCT06289283

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

Sponsor: Theodor Bilharz Research Institute

View on ClinicalTrials.gov

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.

Official title: Profiling Urinary Microbiota In Male Patients With Bladder Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

38

Start Date

2023-10-12

Completion Date

2026-12

Last Updated

2024-03-01

Healthy Volunteers

Yes

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

Locations (1)

Theodor Bilharz Research Institute

Cairo, Egypt