Clinical trial NCT04647981: Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.
Official title: Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test in the Surveillance of Patients With Non-Invasive Bladder Urothelial Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Invasive Bladder Urothelial Carcinoma
Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade
Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade
Keywords: Bladder
Cancer
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
Collaborators: name: Cepheid
name: Team Languedoc Mutualité / Nouvelles technologies
First posted: 2020-12-01
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A person with antecedents of non-invasive bladder tumors and who has had previous transurethral resection of bladder tumor.

Brief summary: Non-muscle invasive bladder tumor is a condition that can recur with a risk of progression to an infiltrating tumor of the muscle. Regular follow-up is therefore essential to detect any recurrence or progression of the disease as early as possible.

Currently, the monitoring of this type of tumor is done by cystoscopy (examination that allows visualization of the bladder wall) associated with urinary cytology (analysis of urine to detect an abnormality). These examinations have their limits, they may not detect certain types of tumors or may be painful.

To reduce the number of cystoscopies and replace urinary cytology, several urinary markers have been developed in recent years. This is the case of the Xpert® Bladder Cancer Monitor test, which is a non-invasive, in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer.

The purpose of this study is to evaluate the diagnostic performance of the Xpert® Bladder Cancer Monitor test for the detection of bladder tumor recurrence, compared to reference tests.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test.
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
state: Hérault
Study officials:
affiliation: Clinique Beau Soleil
name: Mohamed Trabelssi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: