About this trial
The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of bladder cancer
Negative urine culture
Histological confirmation of urothelial carcinoma
Patients undergoing radical cystectomy
Disqualifiers
Presence of other neoplasias
History of previous BCG therapy
Use of indwelling catheter
Active antibiotic treatment with two months prior to participation
Trial population
Patients affected by bladder cancer, no pathologic/healthy and patients with benign urinary disease. * Men * Fifty to seventy years of age * Written informed consent provided * compliants subjects able to follow the study protocol
Trial design
Other
Prospective
Treatments tested in this trial
Investigating differences in the bladder microbiome
Other interventionUrine samples and tissue from radical cystectomy specimens will be analyzed for the assessment of the urinary microbiome. The 16s rRNA gene will be amplified and the resulting amplicons analyzed by Illumina sequencing. To distinguish contaminants, DNA from the sample will be quantified by qPCR and compared to a known urine sample of E. coli. DNA will be extracted using the Quiagen kit and stored at -20 °C until PCR amplification. Bacterial DNA will be amplified with specific primers covering the V1-V3 hypervariable region of the 16S rRNA gene. Libraries will be prepared using the Illumina 16S microbiome sequencing protocol, and their quality will be verified by Bioanalyzer and quantity by qPCR. Sequencing will be performed in "paired-end" mode on Illumina sequencers. Alpha, beta diversity and species richness will be measured.
Treatment groups
Trial outcomes
Primary outcomes
Differences in the bladder microbiome
To investigate differences in the bladder microbiome in men with bladder cancer, healthy men, and men with benign urinary disease. The study involves collecting urine using a mid-stream clean-catch technique. Subsequent DNA extraction, sequencing, and identification will allow the study of the bacteria within the samples. In this way, variations in bacterial profiles between patients will be measured.
Sponsors and contacts
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