MICROBIOTA AND BLADDER CANCER (MICROBLADDERK)

Centre Hospitalier Universitaire de Nice

Status: Not yet enrolling

Conditions: Bladder (Urothelial, Transitional Cell) Cancer

Treatments: Biological: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07080333

2025-A01185-44 (Other Identifier)

23-API-02

Details and patient eligibility

About

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.

Enrollment: 95 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Antibiotic use within 3 months prior to inclusion
• Current urinary tract infection (urine culture recommended by the AFU prior to RTUV)
• History of surgical treatment of the urinary and genital tracts within the last 6 months prior to inclusion
• 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

patient with suspected bladder cancer

Experimental group

Treatment:

Biological: biopsy