Bladder (Urothelial, Transitional Cell) CancerMICROBLADDERKNCT07080333
MICROBIOTA AND BLADDER CANCER
A study testing biopsy in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 8 sitesFrance
- Study dates
- 23 Mar 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Cannes Hospital
Cannes, 06141
Romain HAIDER, 04 92 18 37 70, R.HAIDER@ch-cannes.fr
Romain HAIDER
- Not yet recruiting
Marseille university Hospital
Marseille, 13000
Romain BOISSIER, 04 91 43 51 70, Romain.Boissier@ap-hm.fr
Romain BOISSIER
- Not yet recruiting
Menton Hospital
Menton, 06507
Khaled YOUSSEF, 04.93.28.72.60, k.youssef@ch-menton.fr
Khaled YOUSSEF
- Recruiting
Nice University Hospital
Nice, 06000
Alice GAUDART, 0492036214, gaudart.a@chu-nice.fr
Romain LOTTE, lotte.r@chu-nice.fr
- Not yet recruiting
Nimes University hospital
Nîmes, 30029
Stephane DROUPY, 04 92 03 46 72, droupy.s@chu-nimes.fr
Stephane DROUPY
- Not yet recruiting
Paris University Hospital
Paris, 75018
Jean françois HERMIEU, 01 40 25 71 03, jean-francois.hermieu@bch.aphp.fr
Jean François HERMIEU
- Not yet recruiting
Rennes University Hospital
Rennes, 35033
Romain MATHIEU, 02 99 28 42 70, romain.MATHIEU@chu-rennes.fr
Romain MATHIEU
- Not yet recruiting
Tours University Hospital
Tours, 37044
Ali BOURGI, 02 47 47 39 17, ali.bourgi@univ-tours.fr
About this study
Official title: BLADDER 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.
- Being tested
- biopsy
- Keywords
- Bladder, cancer, microbiota
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| patient with suspected bladder cancer | Experimental | Not described Receives: Biological: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biodiversity of the bacterial bladder microbiota by global metagenomics
description of biodiversity of bacterial bladder microbiota
Measured: 36 months
Secondary outcomes (1)
Global biodiversity of viral microbiota by metagenomics
description of global biodiversity of viral microbiota
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start23 Mar 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080333
- Sponsor's protocol ID
- 23-API-02
- Other IDs
- 2025-A01185-44
- Acronym
- MICROBLADDERK
- Status last verified
- May 2026
- First submitted
- 15 Jul 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLADDER MICROBIOTA AND BLADDER CANCER
- ClinicalTrials.gov ID
- NCT07080333
- Acronym / sponsor ID
- MICROBLADDERK / 23-API-02
- Keywords
- Bladder, cancer, microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with suspected bladder cancer | Experimental | Biological: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyAfter 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. | Biological | patient with suspected bladder cancer |
Primary outcome
The biodiversity of the bacterial bladder microbiota by global metagenomics
Time frame: 36 months
description of biodiversity of bacterial bladder microbiota
1 secondary outcome
Global biodiversity of viral microbiota by metagenomics
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Bladder (Urothelial, Transitional Cell) Cancer, run by Centre Hospitalier Universitaire de Nice at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice GAUDART (04 92 03 62 14, gaudart.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The biodiversity of the bacterial bladder microbiota by global metagenomics (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.