AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU)

April 24, 2026 updated by: Association Francaise d'Urologie
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Aix-en-Provence, France, 13080
        • Recruiting
        • Hôpital Privé de Provence
        • Contact:
      • Angers, France, 49933
      • Arras, France, 62000
        • Recruiting
        • Hôpital privé Arras les Bonnettes
        • Contact:
      • Aubergenville, France, 78410
        • Recruiting
        • Centre hospitalier Privé Montgradé
        • Contact:
      • Beauvais, France
        • Recruiting
        • Centre Hospitalier Beauvais Simone Veil
        • Contact:
      • Caen, France
      • Cesson-Sévigné, France
      • Cornebarrieu, France
      • Eaubonne, France, 95602
      • La Roche-sur-Yon, France
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • CHU Kremlin Bicêtre APHP
        • Contact:
      • Le Mans, France, 72016
      • Le Puy-en-Velay, France
      • Levallois-Perret, France
      • Lorient, France, 56100
      • Lyon, France
      • Lyon, France
      • Lyon, France
      • Mantes-la-Jolie, France
      • Marseille, France
      • Martigues, France
      • Meaux, France
        • Recruiting
        • Grand Hôpital de l'Est-Francilien
        • Contact:
      • Montpellier, France
      • Nîmes, France
      • Paris, France, 75014
        • Recruiting
        • GH Paris Saint Joseph
        • Contact:
      • Paris, France, 75010
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou APHP
        • Contact:
      • Paris, France
        • Recruiting
        • GH Pitié-Salpêtrière APHP
        • Contact:
      • Perpignan, France, 66000
      • Pontoise, France
      • Pringy, France
      • Quint-Fonsegrives, France
      • Rouen, France
      • Rouen, France
      • Royan, France
      • Saint-Germain-en-Laye, France
      • Saint-Grégoire, France, 35760
      • Saint-Herblain, France, 44800
      • Saint-Jean, France
      • Saint-Nazaire, France, 44600
      • Saintes, France, 17100
        • Recruiting
        • Centre Hospitalier de Saintonge
        • Contact:
      • Suresnes, France
      • Tarbes, France, 65000
      • Toulouse, France, 31076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient being monitored for a non-urothelial bladder tumor
  • Patient refusing follow-up
  • Opposition to participation in the study
  • Adult protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival
Time Frame: 5 years
New bladder cancer (Whether NMIBC or MIBC).
5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 5 years
New bladder cancer (MIBC).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise d'Urologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

February 1, 2035

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Registry TVNIM-AFU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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