NCT06992986 Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population
| NCT ID | NCT06992986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2025-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-02-06 with a primary completion date of 2025-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Giuseppe Simone, Doctor
PRINCIPAL INVESTIGATOR
IRCCS National Cancer Institute
Frequently Asked Questions
Who can join the NCT06992986 clinical trial?
This trial is open to male participants only, aged 50 Years or older, up to 70 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992986 currently recruiting?
Yes, NCT06992986 is actively recruiting participants. Contact the research team at giuseppe.simone@ifo.it for enrollment information.
Where is the NCT06992986 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06992986 clinical trial?
NCT06992986 is sponsored by Regina Elena Cancer Institute. The principal investigator is Giuseppe Simone, Doctor at IRCCS National Cancer Institute. The trial plans to enroll 50 participants.
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