Clinical trial · Observational
Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population
Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study
NCT06992986CI-TRIAL-00090249recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigating differences in the bladder microbiome | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Patients with malignant disease
- description
- 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.
- interventionNames
- Other: Investigating differences in the bladder microbiome
- label
- Non-pathological control subjects/"healthy" controls
- description
- 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.
- interventionNames
- Other: Investigating differences in the bladder microbiome
- label
- Control patients with "benign" pathologies
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.