NCT06992986

Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population

Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease

Detailed description

The presence of diverse bacterial representations characterizes a healthy microbiome in both men and women. Differences in bacterial diversity and richness have been observed in subjects with bladder cancer. Investigating the complex relationship between the urinary microbiome and bladder cancer is imperative and requires extensive exploration. The urinary microbiome in patients with bladder cancer has shown high variability in results between studies. These differences may suggest an interaction with bladder tissue and a potential association; however, it is still unclear whether this association precedes or follows bladder cancer. Regarding phylum-level representations, an abundance of Proteobacteria and Corynebacterium, and a decreased abundance of the genera Ruminococcus and Bifidobacterium have been identified in patients with bladder cancer. The latter two are considered anti-inflammatory bacteria important for mucosal homeostasis. Furthermore, with regard to tumor grade, an increase in Veillonella has been reported in pTa/T1Hg, CIS and T2 tumors; Corynebacterium and Staphylococcus are increased in high-grade NMIBC and low-grade pTa tumors, respectively. The study aims to investigate possible differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects. Furthermore, possible variations in bacterial profiles in patients with bladder cancer based on tumor stage will be investigated. differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects. In addition to possible variations in bacterial profiles in patients with bladder cancer based on tumor stage.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Investigating differences in the bladder microbiome	Urine 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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-07-06
• Completion: 2025-07-06
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: Italy