Bladder CancerVISIOCYT 1NCT02966691
Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
A study testing VisioCyt® diagnostic test in people with Bladder Cancer, run by Vitadx at 14 sites in France.
Trial summary
This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. 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?
- VisioCyt® diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 14 sitesFrance
- Study dates
- 24 Jan 2017to 16 Jan 2021
- 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
- Age ≥18 years
- Patient affiliated to a social security system
- Patient able to understand the protocol.
- Signature of patient consent form before the start of the study
- Negative urine culture
- Patient for which is programmed a bladder Endoscopy for :
- suspected bladder cancer (de novo, monitoring or relapse)
- Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer
Who cannot join
- Age <18 years
- Ongoing Urinary tract infection untreated
- Private person of liberty or under guardianship (including guardianship)
- Bladder cancer excluding urothelial carcinoma
- Carcinoma of high urinary tract, associated
- Lithiasis pathology
- Patient who underwent renal transplantation
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Hôpital d'Antony
Antony
Clinique " la Châtaigneraie "
Beaumont
CHU de Besançon
Besançon, 25000
CHU de Clermont-Ferrand
Clermont-Ferrand
Hôpital Edouard Herriot
Lyon
Institut Paoli-Calmettes
Marseille, 13009
Clinique BeauSoleil
Montpellier, 34070
Hôtel Dieu, CHR de Nantes
Nantes, 44093
CHU Caremeau, Nimes
Nîmes, 30029
Hôpital Cochin
Paris
CHU Rennes
Rennes, 35033
Hôpital Foch
Suresnes
Hopital Rangueil
Toulouse
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
About this study
This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.
Read the detailed description
This clinical trial is divided into two main phases:
- The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.
II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.
- Conditions
- Bladder Cancer
- Being tested
- VisioCyt® diagnostic test
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisioCyt® diagnostic testOther
The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
| Study group | Role | What they receive |
|---|---|---|
| Patients 'sick' | Active comparator | The patients of this arm have a clinical signs of bladder cancer with :
* a positive result of bladder endoscopy
* or an negative endoscopy and a positive result of the conventional cytology
The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice .This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized Receives: Other: VisioCyt® diagnostic test |
| Patients 'healthy' | Active comparator | The patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology.
The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized. Receives: Other: VisioCyt® diagnostic test |
| Patients 'monitoring' | Active comparator | The patients of this arm have a history of bladder cancer, but the results of their follow up examinations (cytologic and endoscopic) are negative (no tumor).
The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized. Receives: Other: VisioCyt® diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and classification of cells with the VisioCyt test to create an image processing algorithm
- Identification and classification of cells, taking the Paris System in 2016 as a referential
Measured: 9 months
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
presence or absence of a membrane fluorescence perished, on slides
Measured: 9 months
sensitivity of urinalysis by VisioCyt test
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
Measured: through the study completion
specificity of urinalysis by VisioCyt test
number of patients "declared negative" with the VisioCyt test among the really healthy patients
Measured: through the study completion
Secondary outcomes (4)
sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma
Measured: through the study completion
sensitivity of urinalysis by VisioCyt test according to medical history of the patients
number of patients "declared positive" with the VisioCyt test among the patients with a first diagnosis of bladder carcinoma or among patients with a previous bladder carcinoma under monitoring
Measured: through the study completion
comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology
Measured: through the study completion
comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology
Measured: through the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start24 Jan 2017
- Primary completion31 Dec 2020
- Study completion16 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitadx
- Sponsor type
- University, hospital or other
- Collaborators
- FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE, SATT Paris Saclay
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966691
- Sponsor's protocol ID
- 2016-A00623-48
- Acronym
- VISIOCYT 1
- Status last verified
- Dec 2021
- First submitted
- 28 Oct 2016
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabon S, Brihi S, Fezzani R, Pierre-Jean M, Cuggia M, Bouzille G. Combining a Risk Factor Score Designed From Electronic Health Records With a Digital Cytology Image Scoring System to Improve Bladder Cancer Detection: Proof-of-Concept Study. J Med Internet Res. 2025 Jan 22;27:e56946. doi: 10.2196/56946.
PubMed 39841985
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors
- ClinicalTrials.gov ID
- NCT02966691
- Acronym / sponsor ID
- VISIOCYT 1 / 2016-A00623-48
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- VitadxUniversity, hospital or other
- Collaborators
- FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE, SATT Paris Saclay
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 16 Jan 2021 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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 clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.
Detailed description
This clinical trial is divided into two main phases:
- The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.
II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients 'sick' | Active comparator | Other: VisioCyt® diagnostic testThe patients of this arm have a clinical signs of bladder cancer with : * a positive result of bladder endoscopy * or an negative endoscopy and a positive result of the conventional cytology The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice .This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized |
| Patients 'healthy' | Active comparator | Other: VisioCyt® diagnostic testThe patients of this arm have no suspicion of bladder cancer with negative results of their bladder endoscopy and conventional cytology. The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized. |
| Patients 'monitoring' | Active comparator | Other: VisioCyt® diagnostic testThe patients of this arm have a history of bladder cancer, but the results of their follow up examinations (cytologic and endoscopic) are negative (no tumor). The intervention consists to collect an additional urine sample (50 ml), the day of the bladder endoscopy, which is performed during the current practice . This urine sample will be used for the preparation of cytology slides according to the Visiocyt protocol, in order to be digitized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Patient affiliated to a social security system
- Patient able to understand the protocol.
- Signature of patient consent form before the start of the study
- Negative urine culture
Key exclusion criteria (7 listed)
- Age <18 years
- Ongoing Urinary tract infection untreated
- Private person of liberty or under guardianship (including guardianship)
- Bladder cancer excluding urothelial carcinoma
- Carcinoma of high urinary tract, associated
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 |
|---|---|---|
| VisioCyt® diagnostic testThe cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm. | Other | Patients 'healthy', Patients 'monitoring', Patients 'sick' |
Primary outcome
Identification and classification of cells with the VisioCyt test to create an image processing algorithm
Time frame: 9 months
* Identification and classification of cells, taking the Paris System in 2016 as a referential
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
Time frame: 9 months
presence or absence of a membrane fluorescence perished, on slides
sensitivity of urinalysis by VisioCyt test
Time frame: through the study completion
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
specificity of urinalysis by VisioCyt test
Time frame: through the study completion
number of patients "declared negative" with the VisioCyt test among the really healthy patients
4 secondary outcomes
sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
Time frame: through the study completion
sensitivity of urinalysis by VisioCyt test according to medical history of the patients
Time frame: through the study completion
comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
Time frame: through the study completion
comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
Time frame: through the study completion
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 6 Jan 2022.
- Derived from this study: PubMed 39841985Cabon S, Brihi S, Fezzani R, Pierre-Jean M, Cuggia M, Bouzille G. Combining a Risk Factor Score Designed From Electronic Health Records With a Digital Cytology Image Scoring System to Improve Bladder Cancer Detection: Proof-of-Concept Study. J Med Internet Res. 2025 Jan 22;27:e56946. doi: 10.2196/56946.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisioCyt® diagnostic test in people with Bladder Cancer, run by Vitadx at 14 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 8 inclusion and 7 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 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
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?
Identification and classification of cells with the VisioCyt test to create an image processing algorithm (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966691, which also lists 1 linked publication.
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 6 Jan 2022.