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

NCT06992986 | Recruiting

• 1 other identifier: RS91/IRE/24
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bladder Cancer

Outcome Measures

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.

  36 months

Study Arms (3)

Patients with malignant disease

Will include 30 patients with tumor pathology (10 non-muscle-invasive and 20 muscle-invasive) in which urine samples will be analyzed and, tissue from radical cystectomy samples, will be used to evaluate the urinary microbiome.

Other: Investigating differences in the bladder microbiome

Non-pathological control subjects/"healthy" controls

Healthy controls will be selected from men with an age within the above-mentioned range, not affected by urinary pathology and/or other overt pathology. Suitable controls will be recruited from the institution's staff and/or visiting for occupational medicine.

Other: Investigating differences in the bladder microbiome

Control patients with "benign" pathologies

This cohort will include individuals with renal cysts, benign prostatic obstruction, ureteropyelic or ureteral obstruction, undergoing surgical therapy. The same exclusion criteria as cohort 2 apply.

Other: Investigating differences in the bladder microbiome

Interventions

Investigating differences in the bladder microbiome OTHER

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.

Control patients with "benign" pathologies; Non-pathological control subjects/"healthy" controls; Patients with malignant disease

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Diagnosis of bladder cancer
• Negative urine culture
• Histological confirmation of urothelial carcinoma
• Patients undergoing radical cystectomy

You may not qualify if:

• Presence of other neoplasias
• History of previous BCG therapy
• Use of indwelling catheter
• Active antibiotic treatment with two months prior to participation
• History of sexual transmitted diseases
• Presence of chronic intestinal inflammation
• Previous neoadyuvant therapy
• \- Controls will be collected from men within the specified age range. Eligible controls may be drawn from the institution's personnel attending the occupational medicine department or in service in the Institute.
• Diabetes
• Chronic Kidney Disease
• Cardiac disease
• Hepatic disease
• To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples and tissue samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Giuseppe Simone, Doctor

  IRCCS National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Simone, Doctor

CONTACT

+39-06-5266.5005; giuseppe.simone@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 28, 2025
• Study Start: February 6, 2024
• Primary Completion: July 6, 2025
• Study Completion: July 6, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

IT (1)