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RECRUITING
NCT06992986

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

Sponsor: Regina Elena Cancer Institute

View on ClinicalTrials.gov

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

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

Key Details

Gender

MALE

Age Range

50 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-02-06

Completion Date

2025-07-06

Last Updated

2025-05-28

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

"Regina Elena" National Cancer Institute

Rome, Italy