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NCT Number: NCT07080333

MICROBIOTA AND BLADDER CANCER

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cannes Hospital, Cannes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biopsy

Biological

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 outcomes

  1. The biodiversity of the bacterial bladder microbiota by global metagenomics

    Time frame: 36 months

    description of biodiversity of bacterial bladder microbiota

Secondary outcomes

  1. Global biodiversity of viral microbiota by metagenomics

    Time frame: 36 months

    description of global biodiversity of viral microbiota

Study contacts

Contact information is provided by the study sponsor or research team.

Alice GAUDART

CONTACT

[email protected]

04 92 03 62 14

Romain LOTTE, MCUPH

CONTACT

[email protected]

04 92 03 62 14

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

BLADDER MICROBIOTA AND BLADDER CANCER

Acronym: MICROBLADDERK

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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