Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterparts in Adult Male Population

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: Investigating differences in the bladder microbiome

Study type: Observational

Funder types: Other

Identifiers

NCT06992986

RS91/IRE/24

Details and patient eligibility

About

The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

50 participants in 3 patient groups

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.

Treatment:

Other: Investigating differences in the bladder microbiome

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.

Treatment:

Other: Investigating differences in the bladder microbiome

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.

Treatment:

Other: Investigating differences in the bladder microbiome