Clinical trial · Observational
Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.
Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test in the Surveillance of Patients With Non-Invasive Bladder Urothelial Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade | Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade | ONTOLOGY_EXACT | 0.98 |
| Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade | Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade | ONTOLOGY_EXACT | 0.98 |
| Non-Invasive Bladder Urothelial Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Xpert® Bladder Cancer Monitor Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Xpert® Bladder Test
- description
- A urine sample is collected before cystoscopy.
- interventionNames
- Other: Xpert® Bladder Cancer Monitor Test
Primary outcomes (1)
- measure
- Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test.
- timeFrame
- 12 months
- description
- The two tests, the Xpert® Bladder Cancer Monitor and the urinary cytology, made during the follow-up of patients with non-invasive-muscle bladder tumor are compared to the gold standard, which is the reference examination: the couple cystoscopy/histology.
Secondary outcomes (1)
- measure
- Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available