Clinical trial · Interventional
Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study
NCT03715660CI-TRIAL-00041834completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems in comparison to the methods currently used at the site for detecting recurrent bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Xpert bladder cancer monitor | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Xpert monitor- evaluated patients
- description
- Xpert Bladder Cancer Monitor performance shall be established in recurrence patients relative to cystoscopy (for disease negative patients) or histology (for disease positive patients)and relative to a currently used diagnostic assay (urine cytology)which is the standard of care used for detecting recurrent bladder cancer at the site. In this study, clinical sensitivity shall be established in patients who have been previously diagnosed with bladder cancer and are scheduled for a standard of care (SOC) surveillance cystoscopy.
- interventionNames
- Diagnostic Test: Xpert bladder cancer monitor
Primary outcomes (1)
- measure
- Accuracy of Xpert Bladder Cancer Monitor in monitoring of non muscle invasive bladder cancer by comparing its results to the results of the standard tool of monitoring of bladder cancer (diagnostic cystoscopy)
- timeFrame
- within 1 month after test assessment
- description
- Xpert Bladder Cancer Monitor performance shall be established in recurrence patients relative to cystoscopy (for disease negative patients) or histology (for disease positive patients)and relative to a currently used diagnostic assay (urine cytology)which is the standard of care used for detecting recurrent bladder cancer at the site. In this study, clinical sensitivity shall be established in patients who have been previously diagnosed with bladder cancer and are scheduled for a standard of care (SOC) surveillance cystoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * The patient shall meet all of the following criteria in order to be considered eligible for enrollment: * Patient has been diagnosed with NMIBC within 24 months of enrollment * At the time of the enrollment visit, the patient is scheduled for a cystoscopy within the next 6 weeks of enrollment Exclusion Criteria: * Patient has had an excision procedure or BCG treatment within six weeks (42 days) before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.