Status:
RECRUITING
Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Bladder Cancer
Eligibility:
MALE
50-70 years
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
Detailed Description
The presence of diverse bacterial representations characterizes a healthy microbiome in both men and women. Differences in bacterial diversity and richness have been observed in subjects with bladder ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Bladder Cancer Patients):
- Diagnosis of bladder cancer
- Negative urine culture
- Histological confirmation of urothelial carcinoma
- Patients undergoing radical cystectomy
- Exclusion Criteria:
- 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
- Inclusion Criteria Controls No-Pathologic/Healthy):
- \- 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.
- Exclusion Criteria:
- Diabetes
- Chronic Kidney Disease
- Cardiac disease
- Hepatic disease
- Inclusion Criteria(Benign Urinary 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.
- Exclusion Criteria:
- NA
Exclusion
Key Trial Info
Start Date :
February 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 6 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06992986
Start Date
February 6 2024
End Date
July 6 2025
Last Update
May 28 2025
Active Locations (1)
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1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144