Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05002556 En recrutement IDF

Titre

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

Type

Observational

Pathologie

Tumeurs de la vessie urinaire

Phase

Promoteur

Association Francaise d'Urologie (Voir sur ClinicalTrials)

Date de début

février 2023

Date de fin

décembre 2033

Dernière mise à jour

01 mai 2025

Résumé

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.

Détail

Voir le détail 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. Urine sampling is recommended prior to bladder endoscopy for follow-up of NMIBC to ensure urine sterility (CBEU) and to perform urine cytology in patients with high-grade NMIBC and/or carcinoma in situ. The observational study of the clinical validity of the negative and positive predictive values of the biomarkers 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 biomarkers available in France, performed on a urine sample and providing 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 biomarkers. 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 biomarker carried out before the resection (biopsy). At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (white light 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 3-year period. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH	YANN NEUZILLET	En recrutement IDF	05/05/2025 07:12:10	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL NOVO	Stéphane Bart	En recrutement IDF		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier Annecy Genevois - Pringy - France	Olivier Skowron	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Beauvais Simone Veil - Beauvais - France	Luu Le Van	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Martigues - Martigues - France	Harry Toledano	En recrutement		Contact (sur clinicalTrials)
CHD Vendée - La Roche sur Yon - France	Constance Deboudt-Macé	En recrutement		Contact (sur clinicalTrials)
CHU Caen - Caen - France	Romain Lefranc	En recrutement		Contact (sur clinicalTrials)
CHU Kremlin Bicêtre (APHP) - Le Kremlin-Bicêtre - France	Cedric Lebacle	En recrutement		Contact (sur clinicalTrials)
CHU Nimes - Nimes - France	Stephane Droupy	En recrutement		Contact (sur clinicalTrials)
Clinique Beau Soleil - Montpellier - France	Gregoire Poinas	En recrutement		Contact (sur clinicalTrials)
Clinique Bon Secours - Le Puy en Velay - France	Marlene Guandalino	En recrutement		Contact (sur clinicalTrials)
Clinique de la Région Mantaise - Mantes la Jolie - France	Medhi Ariane	En recrutement		Contact (sur clinicalTrials)
Clinique de la Sauvegarde - Lyon - France	Emmanuel Deligne	En recrutement		Contact (sur clinicalTrials)
Clinique de l'Union - Saint Jean - France	Raphael Benhaim	En recrutement		Contact (sur clinicalTrials)
Clinique des Cèdres - Cornebarrieu - France	Olivier Merigot de Treigny	En recrutement		Contact (sur clinicalTrials)
Clinique la Croix du Sud - Quint-Fonsegrives - France	Benjamin Pradere	En recrutement		Contact (sur clinicalTrials)
Clinique Mathilde - Rouen - France	Blandine Tamarelle	En recrutement		Contact (sur clinicalTrials)
Clinique Pasteur - Royan - France	Priscilla Leon	En recrutement		Contact (sur clinicalTrials)
Clinique Saint Germain en laye - Saint Germain en Laye - France	Dimitri Gambachidze	En recrutement		Contact (sur clinicalTrials)
Clinique Saint Hilaire - Rouen - France	Benoit Malval	En recrutement		Contact (sur clinicalTrials)
Grand Hôpital de l'Est-Francilien - Meaux - France	Julien Sarkis	En recrutement		Contact (sur clinicalTrials)
Hopital Edouard Heriot - Lyon - France	Marc Colombel	En recrutement		Contact (sur clinicalTrials)
Hopital Foch - Suresnes - France	Yann Neuzillet	En recrutement		Contact (sur clinicalTrials)
Hopital Franco-Britannique Cognac Jay - Levallois-Perret - France	Caroline Pettenati	En recrutement		Contact (sur clinicalTrials)
Hopital Lyon Sud - Lyon - France	Alain Ruffion	En recrutement		Contact (sur clinicalTrials)
Hôpital Pitié-Salpêtrière - Paris - France	Morgan Roupret	En recrutement		Contact (sur clinicalTrials)
Hôpital Privé de Sévigné - Cesson-Sévigné - France	Philippe Guiraud	En recrutement		Contact (sur clinicalTrials)
Hôpital privé Européen - Marseille - Marseille - France	Julien Deturmeny	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Patient being monitored for a non-muscle-invasive bladder tumor and having undergone
a urinary molecular 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.

Critère de non inclusion

- Patient being monitored for a non-urothelial bladder tumor

- Patient refusing follow-up

- Opposition to participation in the study

- Adult protected by law

NCT05002556 - AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut