Non-Muscle-Invasive Bladder CancerTVNIM-AFUNCT05002556
AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
An observational study of Non-Muscle-Invasive Bladder Cancer, run by Association Francaise d'Urologie at 44 sites in France.
Trial summary
The AFU has set itself the task of setting up a register of medical practices in order to define possible improvements in the therapeutic management and follow-up of NMIBC. In order to obtain representative data, all urologists who are members of the AFU may be invited to include their patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer
- How many people
- 8,000 participants
- Where
- 44 sitesFrance
- Study dates
- 21 Feb 2023to Feb 2035
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary test (biomarker) prior to their resection (biopsy) diagnosis or recurrence
Who may be able to join
- Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary test (biomarker) prior to their resection (biopsy) diagnosis or recurrence,
- AND adult (equal to or > 18 years old),
- AND affiliated with a social security scheme in France,
- AND whose monitoring will be carried out at the recruiting center.
Who cannot join
- Patient being monitored for a non-urothelial bladder tumor
- Patient refusing follow-up
- Opposition to participation in the study
- Adult protected by law
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
France44 sites, 44 recruiting
- Recruiting
Hopital Prive de Provence
Aix-en-Provence, 13080
Arnaud MONGES, MD, +33, a.monges@hpp13.com
- Recruiting
CHU Angers
Angers, 49933
Pierre Bigot, MD, PhD, +33, pibigot@chu-angers.fr
- Recruiting
Hopital Privé Arras les Bonnettes
Arras, 62000
Frederic BOUTEMY, MD, +33, frederic.boutemy@ramsay.fr
- Recruiting
Centre hospitalier Privé Montgradé
Aubergenville, 78410
Elia YOUNES, MD, +33, eyounes@vivalto-sante.com
- Recruiting
Centre Hospitalier Beauvais Simone Veil
Beauvais
Luu Le Van, +33, l.levan@ch-beauvais.fr
- Recruiting
CHU Caen
Caen
Romain Lefranc, +33, lefranc-r@chu-caen.fr
- Recruiting
Hôpital Privé de Sévigné
Cesson-Sévigné
Philippe Guiraud, +33, pguiraud@vivalto-sante.com
- Recruiting
Clinique des Cèdres
Cornebarrieu
Olivier Merigot de Treigny, +33, laure.combes@ramsaysante.fr
- Recruiting
GH Eaubonne-Montmorency Hopital Simone Veil
Eaubonne, 95602
Alaa ABDELWAHAB, MD, +33, alaa.abdelwahab@ch-simoneveil.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Constance Deboudt-Macé, +33, constance.deboudt@ght85.fr
- Recruiting
CHU Kremlin Bicêtre APHP
Le Kremlin-Bicêtre
Cedric Lebacle, +33, cedric.lebacle@aphp.fr
- Recruiting
Pôle Santé Sud
Le Mans, 72016
Maximilien BARON, MD, +33, maximilien.baron@elsan.care
- Recruiting
Clinique Bon Secours
Le Puy-en-Velay
Marlene Guandalino, +33, lesmontsduro@gmail.com
- Recruiting
Hopital Franco-Britannique Cognac Jay
Levallois-Perret
Caroline Pettenati, +33, caroline.pettenati@cognacq-jay.fr
- Recruiting
Clinique Mutualiste de la porte de l'Orient
Lorient, 56100
Louis Sauty, MD, +33, louis.sauty@hospigrandouest.fr
- Recruiting
Clinique de la Sauvegarde
Lyon
Emmanuel Deligne, +33, emmanuel.deligne@ramsaysante.fr
- Recruiting
Hopital Edouard Heriot
Lyon
Marc Colombel, +33, marc.colombel@chu-lyon.fr
- Recruiting
Hopital Lyon Sud
Lyon
Alain Ruffion, +33, alain.ruffion@chu-lyon.fr
- Recruiting
Clinique de la Région Mantaise
Mantes-la-Jolie
Medhi Ariane, +33, mariane@vivalto-sante.com
- Recruiting
Hôpital privé Européen - Marseille
Marseille
Julien Deturmeny, +33, j.deturmeny@hopital-europeen.fr
- Recruiting
Centre Hospitalier Martigues
Martigues
Harry Toledano, +33, Harry.TOLEDANO@ch-martigues.fr
- Recruiting
Grand Hôpital de l'Est-Francilien
Meaux
Julien Sarkis, +33, jsarkis@ghef.fr
- Recruiting
Clinique Beau Soleil
Montpellier
Gregoire Poinas, +33, secretariat.uro@languedoc-mutualite.fr
- Recruiting
CHU Nimes
Nîmes
Stephane Droupy, +33, stephane.DROUPY@chu-nimes.fr
- Recruiting
CH Saint-Louis APHP
Paris, 75010
Alexandra Masson-Lecomte, MD, PhD, +33, alexandra.massonlecomte@aphp.fr
- Recruiting
GH Paris Saint Joseph
Paris, 75014
Constance MICHEL, MD, +33, cmichel@ghpsj.fr
- Recruiting
Hôpital Européen Georges Pompidou APHP
Paris, 75015
Francois AUDENET, MD, PhD, +33, francois.audenet@aphp.fr
- Recruiting
GH Pitié-Salpêtrière APHP
Paris
Morgan Roupret, +33, morgan.roupret@aphp.fr
- Recruiting
CH Perpignan
Perpignan, 66000
Tarek DJELOUAT, MD, +33, tarek.djelouat@ch-perpignan.fr
- Recruiting
GHT Novo - CH René Dubos Pontoise
Pontoise
Stéphane Bart, +33, stephane.bart@ght-novo.fr
- Recruiting
Centre Hospitalier Annecy Genevois
Pringy
Olivier Skowron, +33, oskowron@ch-annecygenevois.fr
- Recruiting
Clinique la Croix du Sud
Quint-Fonsegrives
Benjamin Pradere, +33, laure.combes@ramsaysante.fr
- Recruiting
Clinique Mathilde
Rouen
Blandine Tamarelle, +33, btamarelle@vivalto-sante.com
- Recruiting
Clinique Saint Hilaire
Rouen
Benoit Malval, +33, fhupel@clinique-sainthilaire.fr
- Recruiting
Clinique Pasteur
Royan
Priscilla Leon, +33, pleon@vivalto-sante.com
- Recruiting
Clinique Saint Germain en laye
Saint-Germain-en-Laye
Dimitri Gambachidze, +33, dgambachidze@vivalto-sante.com
- Recruiting
Hopital Privé Saint Grégoire
Saint-Grégoire, 35760
Edouard TARIEL, MD, +33, etariel@vivalto-sante.com
- Recruiting
Clinique Santé Atlantique
Saint-Herblain, 44800
Quentin-Côme LE CLERC, MD, +33, quentincome.leclerc@elsan.care
- Recruiting
Clinique de l'Union
Saint-Jean
Raphael Benhaim, +33, laure.combes@ramsaysante.fr
- Recruiting
Polyclinique de l'Europe
Saint-Nazaire, 44600
Louis Marconnet, MD, +33, lmarconnet@vivalto-sante.com
- Recruiting
Centre Hospitalier de Saintonge
Saintes, 17100
Guillaume Hugues, MD, +33, g.hugues@ch-saintonge.fr
- Recruiting
Hopital Foch
Suresnes
Yann Neuzillet, +33, y.neuzillet@hopital.foch.com
- Recruiting
Polyclinique de l'Ormeau
Tarbes, 65000
Guillaume NORMAND, MD, +33, guillaume.normand@elsan.care
- Recruiting
Clinique Pasteur
Toulouse, 31076
Julien GUILLOTREAU, MD, +33, jguillotreau@clinique-pasteur.com
About this study
The AFU has set itself the task of setting up a register of medical practices in order to define possible improvements in the therapeutic management and follow-up of NMIBC. In order to obtain representative data, all urologists who are members of the AFU may be invited to include their patients.
Read the detailed description
BACKGROUND Non-muscle infiltrating bladder tumors are a cancerous pathology with an estimated incidence of 13,000 new cases/year in France. ¾ of new cases are diagnosed at a stage where the cancer is of limited extension to the urothelial mucosa and/or its underlying chorion (non-muscle-invasive bladder cancer NMIBC). The management and follow-up of NMIBCs are performed according to the best practice recommendations issued by the Cancer Committee of the French Urology Association. The risk of recurrence at 1 and 5 years for NMIBC has been estimated in clinical trials to be between 15%-61% and 31%-78%, respectively, depending on grade, stage, number, size, frequency of previous recurrence and presence of carcinoma in situ. In this context, patients should have regular endoscopic examinations to ensure the absence of tumor lesions inside their bladder. Urine cytology pathology is recommended for the detection of recurrence of NMIBC. However, the negative predictive value of this examination does not allow it to be substituted for bladder endoscopy, as the risk of not recognizing a bladder tumor, especially of low grade, is too high. To date, no urinary biomarker has been shown to be clinically useful and their use is not recommended for the non-invasive detection of endovesical tumor recurrence.
The observational study of the clinical validity of the negative and positive predictive values of urine tests in a population of patients followed for a bladder tumor previously characterized is able to demonstrate the possibility of postponing the realization of the cystoscopy according to the tumoral characteristics and the treatments received by the patients.
OBJECTIVES The main objective of the research will be to evaluate the diagnostic performance of urine tests, which are available in France and which provide a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of the tests.
The secondary objectives will be to describe the anatomopathological characteristics, the pathological history and the treatments received in the population, as well as analyze demographic and regional disparities in the treatment profiles of these diseases.
MATERIAL AND METHOD When the patient is included in the study, medical data relating to the patient's pathology, including all previous treatments, will be entered into the register, as well as the name and result of the urine test carried out before the resection (biopsy) on urine samples taken as part of routine care. At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (bladder fibroscopy). The name and result of the urine test will also be recorded by the urologist. The performance of the test will be evaluated from these data by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of variance (ANOVA) to explore possible differences within the test by tumor grade and stage, and according to previous endovesical treatments received.
The inclusion target is 8000 patients in France over a 6-year period.
- Conditions
- Non-Muscle-Invasive Bladder Cancer
- Keywords
- Bladder cancer, urine test, recurrence
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival
New bladder cancer (Whether NMIBC or MIBC).
Measured: 5 years
Performance of urine tests (biomarkers)
To evaluate the diagnostic performance of urine tests (biomarkers) available in France, and providing a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) correlated to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of biomarkers.
Measured: 5 years
Secondary outcomes (1)
Progression-Free Survival
New bladder cancer (MIBC).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start21 Feb 2023
- Primary completionFeb 2034 (estimated)
- Study completionFeb 2035 (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 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise d'Urologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002556
- Sponsor's protocol ID
- Registry TVNIM-AFU
- Acronym
- TVNIM-AFU
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05002556
- Acronym / sponsor ID
- TVNIM-AFU / Registry TVNIM-AFU
- Conditions
- Non-Muscle-Invasive Bladder Cancer
- Keywords
- Bladder cancer, urine test, recurrence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Association Francaise d'UrologieUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- Feb 2034 (estimated)
- Study completion
- Feb 2035 (estimated)
- First posted
- 12 Aug 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.
The AFU has set itself the task of setting up a register of medical practices in order to define possible improvements in the therapeutic management and follow-up of NMIBC. In order to obtain representative data, all urologists who are members of the AFU may be invited to include their patients.
Detailed description
BACKGROUND Non-muscle infiltrating bladder tumors are a cancerous pathology with an estimated incidence of 13,000 new cases/year in France. ¾ of new cases are diagnosed at a stage where the cancer is of limited extension to the urothelial mucosa and/or its underlying chorion (non-muscle-invasive bladder cancer NMIBC). The management and follow-up of NMIBCs are performed according to the best practice recommendations issued by the Cancer Committee of the French Urology Association. The risk of recurrence at 1 and 5 years for NMIBC has been estimated in clinical trials to be between 15%-61% and 31%-78%, respectively, depending on grade, stage, number, size, frequency of previous recurrence and presence of carcinoma in situ. In this context, patients should have regular endoscopic examinations to ensure the absence of tumor lesions inside their bladder. Urine cytology pathology is recommended for the detection of recurrence of NMIBC. However, the negative predictive value of this examination does not allow it to be substituted for bladder endoscopy, as the risk of not recognizing a bladder tumor, especially of low grade, is too high. To date, no urinary biomarker has been shown to be clinically useful and their use is not recommended for the non-invasive detection of endovesical tumor recurrence.
The observational study of the clinical validity of the negative and positive predictive values of urine tests in a population of patients followed for a bladder tumor previously characterized is able to demonstrate the possibility of postponing the realization of the cystoscopy according to the tumoral characteristics and the treatments received by the patients.
OBJECTIVES The main objective of the research will be to evaluate the diagnostic performance of urine tests, which are available in France and which provide a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of the tests.
The secondary objectives will be to describe the anatomopathological characteristics, the pathological history and the treatments received in the population, as well as analyze demographic and regional disparities in the treatment profiles of these diseases.
MATERIAL AND METHOD When the patient is included in the study, medical data relating to the patient's pathology, including all previous treatments, will be entered into the register, as well as the name and result of the urine test carried out before the resection (biopsy) on urine samples taken as part of routine care. At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (bladder fibroscopy). The name and result of the urine test will also be recorded by the urologist. The performance of the test will be evaluated from these data by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of variance (ANOVA) to explore possible differences within the test by tumor grade and stage, and according to previous endovesical treatments received.
The inclusion target is 8000 patients in France over a 6-year period.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary test (biomarker) prior to their resection (biopsy) diagnosis or recurrence
Key inclusion criteria (4 listed)
- Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary test (biomarker) prior to their resection (biopsy) diagnosis or recurrence,
- AND adult (equal to or > 18 years old),
- AND affiliated with a social security scheme in France,
- AND whose monitoring will be carried out at the recruiting center.
Key exclusion criteria (4 listed)
- Patient being monitored for a non-urothelial bladder tumor
- Patient refusing follow-up
- Opposition to participation in the study
- Adult protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence-Free Survival
Time frame: 5 years
New bladder cancer (Whether NMIBC or MIBC).
Performance of urine tests (biomarkers)
Time frame: 5 years
To evaluate the diagnostic performance of urine tests (biomarkers) available in France, and providing a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) correlated to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of biomarkers.
1 secondary outcome
Progression-Free Survival
Time frame: 5 years
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 30 Apr 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.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Muscle-Invasive Bladder Cancer, run by Association Francaise d'Urologie at 44 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 4 inclusion and 4 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 Yann Neuzillet (+33145480609, registres@afu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 30 Apr 2026.