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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50-70
SponsorRegina Elena Cancer Institute

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Investigating differences in the bladder microbiome

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Patients with malignant disease1 intervention
Group B: Non-pathological control subjects/"healthy" controls1 intervention
Group C: Control patients with "benign" pathologies1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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