Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.

This study consists of a urine sample. During the participant's medical consultation with his/her urologist, for the monitoring of his/her non-invasive bladder tumor(s), a cystoscopy is performed. Before the examination, the participant gives a urine sample, which will be analyzed by the Xpert®Bladder Cancer Monitor test.

The main objective of this non-interventional monocentric study is to compare the sensitivity of the Xpert® Bladder Cancer Monitor test performed on the GeneXpert® system to the sensitivity of cytology.

The reference test is a combination of cystoscopy and histology. The algorithm is as follows: if the cystoscopy is negative, it will be considered that there is no recurrence; if the cystoscopy is positive, a biopsy of the "abnormal" area will be performed and histology will be requested. If the histology is positive, it will be considered that there is a recurrence; otherwise, it will be considered that there is no recurrence.

The gold standard is, therefore, the couple: cystoscopy +/- histology

• A cystoscopy will be considered positive if to the naked eye the urologist sees a macroscopically suspicious lesion (e.g. a budding lesion).
• If the cystoscopy is positive, the urologist will take a sample of the suspect lesion and have it analyzed by the pathologist. If the lesion analyzed has the same histology as the original lesion, it will be considered a recurrence.

Inclusion criteria

• Participant has a social security scheme.
• Participant has signed a form of no objection to the use of the data.
• Participant has had a transurethral resection of bladder tumor revealing non-invasive-muscle bladder tumor prior to inclusion within a maximum of 5 years from the date of diagnosis to the absence of recurrence since then.
• Participant is seen for a follow-up cystoscopy on the day of the visit.

Non-Inclusion Criteria:

• Vulnerable persons (Article L 1121-6 of the Public Health Code).
• Adults subject to legal protection or unable to express their consent (Article 1121-8 of the Public Health Code).
• Persons with a bladder tumor other than a non-invasive bladder tumor (i.e., invasive bladder cancer).
• A person who has undergone bladder tumor resection or therapy with Calmette-Guerin bacilli or with Mitomycin C less than 6 weeks (42 days) prior to inclusion.

Exclusion criteria

• Participant no longer wishing to participate in the study, or in the course of the study with a refusal to use the data until exit from the study.