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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer — Sample sollection 12 months, next generation sequencing ind bioinformatics 6 months, interpretation of data 6 months.
  Biochemestry and molecular biology assessment: 16S Metagenomic Sequencing analysis Whole genomic sequencing (WGS) will be applied to all cases, methodology and quality control are according to the genomic and metagenomic center in the children cancer hospital 57357 who are going to perform the WGS and 16S sequencing on urine and tissue samples. 1- DNA isolation from urine and tissue. Urine specimens (50ml) will be thawed and centrifuged at 7500g, 4°C for 10minutes. The pellet will be used for DNA extraction using Invitrogen™ PureLink™ Microbiome DNA Purification Kit, performed according to manufacturer's protocol. To avoid environmental contamination, all isolations from urine samples and from the reagent-only extraction control will be carried out within a PCR hood. Isolated DNA samples will be placed at -20 °C until PCR amplifcation. DNA will be quantifed using DeNovix dsDNA High Sensitivity Assay Kit (Illumina 2013) . 2- PCR based KABA KAPA Library Quantification Kits contain all

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