Clinical trial NCT05002556: AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
Official title: AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Muscle-Invasive Bladder Cancer
Lead sponsor: Association Francaise d'Urologie
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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.

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Recurrence-Free Survival
timeFrame: 5 years
measure: Performance of biomarkers
timeFrame: 5 years
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beauvais
country: France
facility: Centre Hospitalier Beauvais Simone Veil
city: Caen
country: France
facility: CHU Caen
city: Cesson-Sévigné
country: France
facility: Hôpital Privé de Sévigné
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin Bicêtre (APHP)
city: Le Puy en Velay
country: France
facility: Clinique Bon Secours
city: Levallois-Perret
country: France
facility: Hopital Franco-Britannique Cognac Jay
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Hopital Edouard Heriot
city: Lyon
country: France
facility: Hopital Lyon Sud
city: Mantes la Jolie
country: France
facility: Clinique de la Région Mantaise
city: Marseille
country: France
facility: Hôpital privé Européen - Marseille
city: Martigues
country: France
facility: Centre Hospitalier Martigues
city: Meaux
country: France
facility: Grand Hôpital de l'Est-Francilien
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Pontoise
country: France
facility: GHT Novo - CH René Dubos Pontoise
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Quint-Fonsegrives
country: France
facility: Clinique la Croix du Sud
city: Rouen
country: France
facility: Clinique Mathilde
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Royan
country: France
facility: Clinique Pasteur
city: Saint Germain en Laye
country: France
facility: Clinique Saint Germain en laye
city: Saint Jean
country: France
facility: Clinique de l'Union
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References: