Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
95 participants
INTERVENTIONAL
2025-10-01
2028-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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patient with suspected bladder cancer
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Cannes Hospital
Cannes, , France
Marseille university Hospital
Marseille, , France
Menton Hospital
Menton, , France
Nice University Hospital
Nice, , France
Nimes University hospital
Nîmes, , France
Paris University Hospital
Paris, , France
Rennes University Hospital
Rennes, , France
Tours University Hospital
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A01185-44
Identifier Type: OTHER
Identifier Source: secondary_id
23-API-02
Identifier Type: -
Identifier Source: org_study_id
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