Bladder CancerURODX-FGFR3NCT05151341
Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
A study testing Urine collection (150ml) and Blood sample (20 ml) in people with Bladder Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Urine collection (150ml) and Blood sample (20 ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BOTH GROUPS
- M/F
- Patient agrees to follow study protocol and is able to follow study procedures
- Patient signed, dated and understood consent form
- Patient has a social security scheme
- CASE GROUP
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- Patient is 18 or older
- Patient for whom a bladder cancer recently diagnosed, or backsliding/progression is heavily suspected after the initial fibroscopy
- Patient who hasn't started systemic/oral/radiotheurapeutic pelvic treatment for his/her tumor
- CONTROL GROUP
- Patient between 18 and 45 y/o
- Patient not suspected of having any bladder cancer
- Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology
- Patient who hasn't been exposed to bladder carcinogens (tobacco, industrial carcinogen (ex: coal tar, tar/coal oils, coal pitch and burning coal soot), urinary bilharzia, chemotherapy exposition (cyclophosphamid)
- Patient that had a negative cytopathological exploration of the excretory urinary route OR/AND iconography (pelvic echography, pelvic scanner) OR/AND endoscopy with prior urinary sample
- Patient unscathed of any cancer that might interact with bladder cancer : uterine cancer, prostate cancer, rectal cancer, and metastasis from other cancer or non-urologic tumor invading the bladder
Who cannot join
- Non-treated current urinary infection
- Patient with another pelvic cancer
- Bladder cancer outside of urothelial carcinoma
- Associated carcinoma of the high urinary apparatus
- Patient that received renal transplantation (BK virus)
- Patient that received pelvis radiotherapy (related to prostatic cancer, gynecologic cancer or pelvic digestive cancer)
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- Patient having a JJ catheter
- Refused to signed consent
- Pregnant, susceptible to be, or breast-feeding women
- Person Under guardianship
- Impossibility to submit to medical monitoring because of geographic, social, or mental issues
- CASE GROUP • Under 18y/o
- CONTROL GROUP
- Under 18y/o or above 45 y/o
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.
The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.
The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.
- Conditions
- Bladder Cancer
- Being tested
- Urine collection (150ml), Blood sample (20 ml)
- Keywords
- FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Diagnosis, Cytoloogy
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection (150ml)Diagnostic test
Urine collection will be tacken at inclusion. The sample will be thereafter separate into three to realise different analyzes (standard cytology, Visiocyt test, FGFR3 analysis)
Blood sample (20 ml)Other
Blood sample will be tacken at inclusion, ONLY for "case" patients that agreed upon this. This sample will be addition to the collection for further research.
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy Receives: Diagnostic Test: Urine collection (150ml); Other: Blood sample (20 ml) |
| Control | Experimental | Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology Receives: Diagnostic Test: Urine collection (150ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity
Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
Measured: at inclusion
Secondary outcomes (4)
Sensitivity of the 4 different tests
Sensibility Comparaison between :
- Visiocyt test + FGFR3 analysis
- FGFR3 analysis on its own
- Visiocyt test on its own
- Standard cytology
Measured: at inclusion
Specificity of the 4 different tests
Specificity Comparaison between :
- Visiocyt test + FGFR3 analysis
- FGFR3 analysis on its own
- Visiocyt test on its own
- Standard cytology
Measured: at inclusion
Positive predictive value of the 4 different tests
Positive predictive value between :
- Visiocyt test + FGFR3 analysis
- FGFR3 analysis on its own
- Visiocyt test on its own
- Standard cytology
Measured: at inclusion
Negative predictive value of the 4 different tests
Negative predictive value between :
- Visiocyt test + FGFR3 analysis
- FGFR3 analysis on its own
- Visiocyt test on its own
- Standard cytology
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start13 Dec 2021
- Primary completion12 Dec 2024
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Vitadx
- Responsible party
- Sponsor
- Investigators
- Eschwège Pascal, MD, PhD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151341
- Sponsor's protocol ID
- 2021-A01054-37
- Acronym
- URODX-FGFR3
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer
- ClinicalTrials.gov ID
- NCT05151341
- Acronym / sponsor ID
- URODX-FGFR3 / 2021-A01054-37
- Conditions
- Bladder Cancer
- Keywords
- FGFR3, VisioCyt, Bladder Tumor, Cancer, FGFR3 Mutation, Diagnosis, Cytoloogy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Collaborators
- Vitadx
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 9 Dec 2021 (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.
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.
The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.
The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Diagnostic Test: Urine collection (150ml), Other: Blood sample (20 ml)Patient in whom newly diagnosed, or recurring / progressing bladder cancer is strongly suspected after initial fibroscopy |
| Control | Experimental | Diagnostic Test: Urine collection (150ml)Patient attending or hospitalized for urolithiasis, urinary infections, superior excretory stones or with non suspect urinary symptomatology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- BOTH GROUPS
- M/F
- Patient agrees to follow study protocol and is able to follow study procedures
- Patient signed, dated and understood consent form
- Patient has a social security scheme
Key exclusion criteria (14 listed)
- Non-treated current urinary infection
- Patient with another pelvic cancer
- Bladder cancer outside of urothelial carcinoma
- Associated carcinoma of the high urinary apparatus
- Patient that received renal transplantation (BK virus)
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 |
|---|---|---|
| Urine collection (150ml)Urine collection will be tacken at inclusion. The sample will be thereafter separate into three to realise different analyzes (standard cytology, Visiocyt test, FGFR3 analysis) | Diagnostic test | Case, Control |
| Blood sample (20 ml)Blood sample will be tacken at inclusion, ONLY for "case" patients that agreed upon this. This sample will be addition to the collection for further research. | Other | Case |
Primary outcome
Specificity
Time frame: at inclusion
Specificity comparaison between Visiocyt test + FGFR3 analysis and FGFR3 analysis on its own
4 secondary outcomes
Sensitivity of the 4 different tests
Time frame: at inclusion
Specificity of the 4 different tests
Time frame: at inclusion
Positive predictive value of the 4 different tests
Time frame: at inclusion
Negative predictive value of the 4 different tests
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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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. This study is not recruiting at the moment.
Eschwège Pascal, MD, PhD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine collection (150ml) and Blood sample (20 ml) in people with Bladder Cancer, run by Institut de Cancérologie de Lorraine at 1 site 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 16 inclusion and 14 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: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity (time frame: at inclusion). 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 24 Jul 2025.