MICROBIOTA AND BLADDER CANCER
MICROBLADDERK
BLADDER MICROBIOTA AND BLADDER CANCER
2 other identifiers
interventional
95
1 country
8
Brief Summary
In France, bladder cancer (BC) is the fourth leading cause of cancer (14,000 new cases per year). It affects older men (\>60 years old) and smoking is the main identified risk factor (RF). The persistence of a high sex ratio despite the increase in smoking among women has led to research into other environmental RFs for BC, which may include the microbiota. Recently, the concept of urinary microbiota in asymptomatic patients has been accepted. Studies on the urinary microbiota have shown dysbiosis associated with certain urogenital pathologies. Thus, similar to certain dysbiosis of the colonic mucosa microbiota associated with CRC, it is possible that certain bacteria or viruses in the bladder tissue microbiota may be involved in bladder carcinogenesis. An epidemiological study conducted by our laboratory showed a prevalence of BC of 14% (7/50) in patients carrying the bacterium Actinotignum schaalii in their urine. While studies have analysed the urinary microbiota of patients with BC, those comparing the microbiota of cancerous bladder tissue with that of healthy tissue in patients with BC remain few in number, involve a limited number of patients, use uncontrolled sample collection, and have all used 16S rDNA-targeted metagenomics methods to study the composition of the microbiota. The authors show a difference in biodiversity between the microbiota of cancerous bladder tissue and that of healthy tissue. The team hopes to confirm these preliminary results with a multicentre study using a more comprehensive genomic method, global metagenomics. The microbiota of cancerous bladder tissue will be compared with that of healthy bladder tissue in the same patient to highlight any bacterial or viral dysbiosis associated with the cancerous area.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
July 23, 2025
July 1, 2025
2.6 years
July 15, 2025
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The biodiversity of the bacterial bladder microbiota by global metagenomics
description of biodiversity of bacterial bladder microbiota
36 months
Secondary Outcomes (1)
Global biodiversity of viral microbiota by metagenomics
36 months
Study Arms (1)
patient with suspected bladder cancer
EXPERIMENTALInterventions
After verifying the patient's identity, obtaining their informed consent and confirming that there are no immediate contraindications to performing biopsies (haemorrhagic and infectious), the patient will be prepared for RTUV, which will be performed by cystoscopy under anaesthesia in the operating theatre.
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- Male
- First RTUV for suspected CV in the presence of macroscopic haematuria or other clinical signs and/or urinary cytology and/or cystoscopy and/or imaging tests suggestive of CV
- Signed informed consent form
- Affiliation with a social security scheme
You may not qualify if:
- Current urinary tract infection (urine culture recommended by the AFU prior to RTUV)
- History of RTUV
- History of pelvic radiotherapy
- Interstitial cystitis
- Patients with an indwelling urinary catheter
- Vulnerable patients: minors, patients under guardianship or curatorship
- Patients with benign tumours after receipt of the pathological report (inverted papilloma, non-tumour inflammatory lesion)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Cannes Hospital
Cannes, 06141, France
Marseille university Hospital
Marseille, 13000, France
Menton Hospital
Menton, 06507, France
Nice University Hospital
Nice, 06000, France
Nimes University hospital
Nîmes, 30029, France
Paris University Hospital
Paris, 75018, France
Rennes University Hospital
Rennes, 35033, France
Tours University Hospital
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 23, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share