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

• ClinicalTrials.gov Identifier: NCT05002556
• Recruitment Status: Not yet recruiting
• First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Sponsor: Association Francaise d'Urologie
• Information provided by (Responsible Party): Association Francaise d'Urologie

Study Description

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 in accordance with the rules of clinical research.

Condition or disease	Intervention/treatment
Non-Muscle-Invasive Bladder Cancer	Diagnostic Test: Urinary Biomarkers

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-infiltrating bladder tumors, NIMBT). The management and follow-up of NMITVs 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 NMITT 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 NMITV. 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 NMITV to ensure urine sterility (UDEC) and to perform urine cytology in patients with high-grade NMITV 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 fibroscopy according to the tumoral characteristics and the treatments received by the patients.

OBJECTIVE

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 NMVT: 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.

MATERIAL AND METHOD

Before each examination, the participating patients will produce a urine sample of approximately 20 to 40 ml in total dedicated to the determination of the marker proposed by your urologist, made by medical analysis laboratory. 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 investigating 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 2000 patients in France over a 3-year period.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
• Estimated Study Start Date: October 1, 2021
• Estimated Primary Completion Date: October 30, 2024
• Estimated Study Completion Date: October 30, 2029

Groups and Cohorts

Intervention Details:

• Diagnostic Test: Urinary Biomarkers
  Prior to each examination, participating patients will produce a urine sample of approximately 20 to 40 ml in total dedicated to the determination of the marker proposed by your urologist, done by medical analysis laboratory. 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 investigating 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

Outcome Measures

Primary Outcome Measures :

1. Recurrence-Free Survival [ Time Frame: 5 years ]
   New bladder cancer (Whether NMIBC or MIBC).
2. Performance of biomarkers [ Time Frame: 5 years ]
   To evaluate the diagnostic performance of biomarkers available in France, analyzed on a urine sample 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 NMVT: determination of the negative and positive predictive values of biomarkers.

Secondary Outcome Measures :

1. Progression-Free Survival [ Time Frame: 5 years ]
   New bladder cancer (MIBC).

Biospecimen Retention:   Samples Without DNA

Urine samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Able-bodied patients of full age, affiliated to a social security system in France, followed for NMIBC.

Criteria

Inclusion Criteria:

• NMIBC (possibility of non-dominant histologic variants) or urothelial tumor of low malignant potential confirmed by endoscopic resection of one or more bladder tumors and/or bladder biopsies.

Exclusion Criteria:

• Non-urothelial bladder tumor

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Association Francaise d'Urologie
• ClinicalTrials.gov Identifier: NCT05002556
• Other Study ID Numbers: 2021-A01517-34
• First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type