Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test. (NCT04647981) | Clinical Trial Compass
CompletedNot Applicable
Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.
France320 participantsStarted 2019-05-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test.