Actively Recruiting
Bladder Microbiota and Bladder Cancer: Study of Microbial Biodiversity in Cancerous and Healthy Bladder Tissue
Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-26
95
Participants Needed
8
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the urinary microbiota's role in bladder cancer, a common cancer especially affecting men over 60, with smoking as a known risk factor. The study aims to explore whether certain bacteria or viruses in bladder tissue microbiota contribute to bladder cancer development by comparing microbiota from cancerous and healthy bladder tissues in the same patient. This research builds on earlier findings that showed differences in microbiota biodiversity between cancerous and healthy tissues. Participants will undergo biopsies during a procedure called RTUV, performed under anesthesia via cystoscopy in an operating room. The study uses advanced global metagenomics to analyze the bacterial and viral microbiota biodiversity in bladder tissues. This multicenter study will enroll men over 18 undergoing their first RTUV for suspected bladder cancer with specific clinical signs. During the 36-month study, researchers will assess the diversity of bacterial and viral microbiota in bladder tissues. Participants will provide informed consent, and safety will be ensured by screening for infections and contraindications before biopsy. The main measurement is the bacterial microbiota biodiversity, with viral microbiota diversity as a secondary outcome, helping to better understand bladder cancer's microbial environment.
CONDITIONS
Brief Title
MICROBIOTA AND BLADDER CANCER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Male sex
- Undergoing first RTUV procedure for suspected bladder cancer with relevant clinical signs or diagnostic tests
- Signed informed consent form
- Affiliated with a social security scheme
You will not qualify if you...
- Antibiotic use within 3 months prior to inclusion
- Current urinary tract infection
- Surgical treatment of urinary or genital tracts within last 6 months
- History of RTUV procedure
- History of pelvic radiotherapy
- Interstitial cystitis
- Presence of an indwelling urinary catheter
- Vulnerable patients such as minors or those under guardianship
- Patients with benign tumors after pathology report
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a biopsy procedure performed by cystoscopy under anaesthesia in the operating theatre to collect bladder tissue samples.
1 visit (in-person, surgical procedure)
Duration - 36 months
Participants are monitored for microbial biodiversity in bladder tissue over time.
Periodic visits for sample collection and assessments
Trial Site Locations
Total: 8 locations
1
Cannes Hospital
Cannes, France, 06141
Not Yet Recruiting
2
Marseille university Hospital
Marseille, France, 13000
Not Yet Recruiting
3
Menton Hospital
Menton, France, 06507
Not Yet Recruiting
4
Nice University Hospital
Nice, France, 06000
Actively Recruiting
5
Nimes University hospital
Nîmes, France, 30029
Not Yet Recruiting
6
Paris University Hospital
Paris, France, 75018
Not Yet Recruiting
7
Rennes University Hospital
Rennes, France, 35033
Not Yet Recruiting
8
Tours University Hospital
Tours, France, 37044
Not Yet Recruiting
Research Team
A
Alice GAUDART
R
Romain LOTTE, MCUPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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