Clinical trial NCT06992986: Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population
Official title: Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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 cancer. Investigating the complex relationship between the urinary microbiome and bladder cancer is imperative and requires extensive exploration. The urinary microbiome in patients with bladder cancer has shown high variability in results between studies.

These differences may suggest an interaction with bladder tissue and a potential association; however, it is still unclear whether this association precedes or follows bladder cancer. Regarding phylum-level representations, an abundance of Proteobacteria and Corynebacterium, and a decreased abundance of the genera Ruminococcus and Bifidobacterium have been identified in patients with bladder cancer. The latter two are considered anti-inflammatory bacteria important for mucosal homeostasis. Furthermore, with regard to tumor grade, an increase in Veillonella has been reported in pTa/T1Hg, CIS and T2 tumors; Corynebacterium and Staphylococcus are increased in high-grade NMIBC and low-grade pTa tumors, respectively.

The study aims to investigate possible differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects.

Furthermore, possible variations in bacterial profiles in patients with bladder cancer based on tumor stage will be investigated.

differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects. In addition to possible variations in bacterial profiles in patients with bladder cancer based on tumor stage.

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

Primary outcomes:
measure: Differences in the bladder microbiome
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS National Cancer Institute
name: Giuseppe Simone, Doctor
role: PRINCIPAL_INVESTIGATOR
References: