Non-muscle Invasive Bladder Cancer (NMIBC)DMIANCT05176145
Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
A study testing VisioCyt® in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Vitadx at 15 sites in 3 countries.
Trial summary
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- VisioCyt®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 Apr 2022to 31 May 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
- Age ≥18 years old and autonomous
- Patient understanding national language well and able to understand the protocol.
- Patient information and informed consent signature before the start of the study
- Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).
Who cannot join
- Patients who have had total bladder resection or bladder reconstruction
- Age <18 years old
- Person deprived of liberty or under guardianship (including curatorship)
- Bladder cancer outside of urothelial carcinoma
- Associated high urinary tract carcinoma
- Kidney transplant patient (BK virus)
- Pelvic radiotherapy patient (prostate cancer)
- Patients with or under surveillance of a muscle-infiltrating bladder tumor
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
France13 sites, 13 recruiting
- Recruiting
CHU Angers
Angers
Pierre Bigot
- Recruiting
CHU de Caen
Caen, 14000
Xavier Tillou, Pr
- Recruiting
CHU de Clermont Ferrand
Clermont-Ferrand, 63003
Laurent Guy, Pr
- Recruiting
CHU Grenoble
Grenoble
Clément Sarrazin, Pr
- Recruiting
CHU Nantes
Nantes
Jérôme Rigaud, Pr
- Recruiting
Hôpital Bichat-Claude Bernard,
Paris
Evanguelos Xylinas, Pr
- Recruiting
Hôpital Pitié-Salpétrière, APHP
Paris
Rouprêt Morgan, Pr
- Recruiting
Clinique la Croix du Sud
Quint-Fonsegrives, 31130
Benjamin Pradere, Pr
- Recruiting
CHU de Rennes
Rennes
Grégory Verhoest, Dr
- Recruiting
CHU Strasbourg
Strasbourg
Hervé Lang, Pr
- Recruiting
Hopital Foch
Suresnes
Thierry Lebret, Pr
- Recruiting
CHU Toulouse
Toulouse
Mathieu Roumiguié, Dr
- Recruiting
CHU Tours
Tours
Franck Bruyère, Pr
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Académique ERASME
Anderlecht, 1070
Thierry Roumeguere, Pr
Spain1 site, 1 recruiting
- Recruiting
Pr Maria Jose Ribal
Barcelona
Maria Jose Ribal, Pr
About this study
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.
Read the detailed description
VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted .
The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression
- Being tested
- VisioCyt®
- Keywords
- NMIBC, recurrence
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisioCyt®Device
- Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines.
- Urine collection for conventional cytology and VisioCyt® test
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology Receives: Device: VisioCyt® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of VisioCyt® test vs conventional cytology
Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
Measured: 24 months
Secondary outcomes (1)
Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology
Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start5 Apr 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitadx
- Sponsor type
- University, hospital or other
- Collaborators
- FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176145
- Sponsor's protocol ID
- DMIA-2021
- Acronym
- DMIA
- Status last verified
- Oct 2023
- First submitted
- 3 Dec 2021
- Last updated
- 13 Oct 2023
- Results posted
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
- ClinicalTrials.gov ID
- NCT05176145
- Acronym / sponsor ID
- DMIA / DMIA-2021
- Keywords
- NMIBC, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- VitadxUniversity, hospital or other
- Collaborators
- FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 4 Jan 2022 (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.
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.
Detailed description
VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted .
The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Device: VisioCyt®Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old and autonomous
- Patient understanding national language well and able to understand the protocol.
- Patient information and informed consent signature before the start of the study
- Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).
Key exclusion criteria (8 listed)
- Patients who have had total bladder resection or bladder reconstruction
- Age <18 years old
- Person deprived of liberty or under guardianship (including curatorship)
- Bladder cancer outside of urothelial carcinoma
- Associated high urinary tract carcinoma
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®* Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines. * Urine collection for conventional cytology and VisioCyt® test | Device | single arm |
Primary outcome
Performance of VisioCyt® test vs conventional cytology
Time frame: 24 months
Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
1 secondary outcome
Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- 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.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisioCyt® in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Vitadx at 15 sites in 3 countries.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Grojean, PhD (33 (0)383501921, DMIA@fondation-force.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of VisioCyt® test vs conventional cytology (time frame: 24 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 13 Oct 2023.