| NCT ID | NCT07080333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Bladder (Urothelial, Transitional Cell) Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2026-03-23 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07080333 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Bladder (Urothelial, Transitional Cell) Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07080333 currently recruiting?
Yes, NCT07080333 is actively recruiting participants. Contact the research team at gaudart.a@chu-nice.fr for enrollment information.
Where is the NCT07080333 trial being conducted?
This trial is being conducted at Cannes, France, Marseille, France, Menton, France, Nice, France and 4 additional locations.
Who is sponsoring the NCT07080333 clinical trial?
NCT07080333 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 95 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.