RecruitingNCT06992986

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


Sponsor

Regina Elena Cancer Institute

Enrollment

50 participants

Start Date

Feb 6, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting urine samples from three groups — people with bladder cancer, people with benign urinary conditions, and healthy individuals — to investigate whether differences in the urinary microbiome (bacteria living in the urinary tract) can help detect or distinguish bladder cancer. **You may be eligible if...** - You have a confirmed diagnosis of bladder cancer and are having your bladder surgically removed (radical cystectomy), OR - You have a benign urinary condition (such as kidney cysts, enlarged prostate, or urinary obstruction), OR - You are a healthy adult without major medical conditions **You may NOT be eligible if...** - You have another active cancer - You have previously received BCG therapy (a bladder cancer treatment) - You are on current antibiotics or have used them in the past 2 months - You have chronic bowel inflammation - You have diabetes, chronic kidney disease, or heart/liver disease (for the healthy control group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERInvestigating 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

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NCT06992986


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