Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study

Study Overview
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Brief Summary
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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.

Official Title
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Xpert Bladder Cancer Monitor; Prospective, Single, Tertiary-care Center Implementation Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: Xpert bladder cancer monitor


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xpert monitor- evaluated patients<br>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. | Diagnostic Test: Xpert bladder cancer monitor<br>* Xpert Bladder Cancer Monitor, is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer.The test utilizes a voided urine specimen and measures the levels of five targetmRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR). The Xpert Bladder Cancer Monitor is indicated as an aid to standard clinical evaluation in monitoring for bladder cancer recurrence in patients previously diagnosed with bladder cancer and should be used in conjunction with other clinical measures to assess disease recurrence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | within 1 month after test assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non muscle invasive bladder cancer, recurrence, progression