NCT05002556

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
106mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

44 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2023Feb 2035

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2034

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2035

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

11 years

First QC Date

August 4, 2021

Last Update Submit

April 24, 2026

Conditions

Keywords

Bladder cancer, urine test, recurrence

Outcome Measures

Primary Outcomes (2)

  • Recurrence-Free Survival

    New bladder cancer (Whether NMIBC or MIBC).

    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.

    5 years

Secondary Outcomes (1)

  • Progression-Free Survival

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Hopital Prive de Provence

Aix-en-Provence, 13080, France

RECRUITING

CHU Angers

Angers, 49933, France

RECRUITING

Hopital Privé Arras les Bonnettes

Arras, 62000, France

RECRUITING

Centre hospitalier Privé Montgradé

Aubergenville, 78410, France

RECRUITING

Centre Hospitalier Beauvais Simone Veil

Beauvais, France

RECRUITING

CHU Caen

Caen, France

RECRUITING

Hôpital Privé de Sévigné

Cesson-Sévigné, France

RECRUITING

Clinique des Cèdres

Cornebarrieu, France

RECRUITING

GH Eaubonne-Montmorency Hopital Simone Veil

Eaubonne, 95602, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CHU Kremlin Bicêtre APHP

Le Kremlin-Bicêtre, France

RECRUITING

Pôle Santé Sud

Le Mans, 72016, France

RECRUITING

Clinique Bon Secours

Le Puy-en-Velay, France

RECRUITING

Hopital Franco-Britannique Cognac Jay

Levallois-Perret, France

RECRUITING

Clinique Mutualiste de la porte de l'Orient

Lorient, 56100, France

RECRUITING

Clinique de la Sauvegarde

Lyon, France

RECRUITING

Hopital Edouard Heriot

Lyon, France

RECRUITING

Hopital Lyon Sud

Lyon, France

RECRUITING

Clinique de la Région Mantaise

Mantes-la-Jolie, France

RECRUITING

Hôpital privé Européen - Marseille

Marseille, France

RECRUITING

Centre Hospitalier Martigues

Martigues, France

RECRUITING

Grand Hôpital de l'Est-Francilien

Meaux, France

RECRUITING

Clinique Beau Soleil

Montpellier, France

RECRUITING

CHU Nimes

Nîmes, France

RECRUITING

CH Saint-Louis APHP

Paris, 75010, France

RECRUITING

GH Paris Saint Joseph

Paris, 75014, France

RECRUITING

Hôpital Européen Georges Pompidou APHP

Paris, 75015, France

RECRUITING

GH Pitié-Salpêtrière APHP

Paris, France

RECRUITING

CH Perpignan

Perpignan, 66000, France

RECRUITING

GHT Novo - CH René Dubos Pontoise

Pontoise, France

RECRUITING

Centre Hospitalier Annecy Genevois

Pringy, France

RECRUITING

Clinique la Croix du Sud

Quint-Fonsegrives, France

RECRUITING

Clinique Mathilde

Rouen, France

RECRUITING

Clinique Saint Hilaire

Rouen, France

RECRUITING

Clinique Pasteur

Royan, France

RECRUITING

Clinique Saint Germain en laye

Saint-Germain-en-Laye, France

RECRUITING

Hopital Privé Saint Grégoire

Saint-Grégoire, 35760, France

RECRUITING

Clinique Santé Atlantique

Saint-Herblain, 44800, France

RECRUITING

Clinique de l'Union

Saint-Jean, France

RECRUITING

Polyclinique de l'Europe

Saint-Nazaire, 44600, France

RECRUITING

Centre Hospitalier de Saintonge

Saintes, 17100, France

RECRUITING

Hopital Foch

Suresnes, France

RECRUITING

Polyclinique de l'Ormeau

Tarbes, 65000, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yann Neuzillet

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

February 21, 2023

Primary Completion (Estimated)

February 1, 2034

Study Completion (Estimated)

February 1, 2035

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations