Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: t
View:
⁃ Diagnosis of bladder cancer
⁃ Negative urine culture
⁃ Histological confirmation of urothelial carcinoma
⁃ Patients undergoing radical cystectomy
‣ \- 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.
• 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.
Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Giuseppe Simone, Doctor
giuseppe.simone@ifo.it
+39-06-5266.5005
Time Frame
Start Date:2024-02-06
Estimated Completion Date:2025-07-06
Participants
Target number of participants:50
Treatments
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.
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.
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.