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Recruiting NCT07080333

MICROBIOTA AND BLADDER CANCER

No phase Interventional Bladder (Urothelial, Transitional Cell) Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biopsy.
Who it may be relevant to
Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BLADDER MICROBIOTA AND BLADDER CANCER

Overview

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.

Interventions

  • Biological biopsy
    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.

Primary outcome measures

  • The biodiversity of the bacterial bladder microbiota by global metagenomics [Time frame: 36 months]
Secondary outcome measures (1)
  • Global biodiversity of viral microbiota by metagenomics [Time frame: 36 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 8 centers
  • Cannes Hospital — Cannes
  • Marseille university Hospital — Marseille
  • Menton Hospital — Menton
  • Nice University Hospital — Nice
  • Nimes University hospital — Nîmes
  • Paris University Hospital — Paris
  • Rennes University Hospital — Rennes
  • Tours University Hospital — Tours

Identifiers

NCT: NCT07080333 · 23-API-02 · 2025-A01185-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗