Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer

Study Overview
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Brief Summary
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The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.

Official Title
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Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Xpert Bladder Cancer Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 40 years of age Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states. Subject is considered disease positive within 12 months (365 days) of enrollment. At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen. Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit. Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort. Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled. Exclusion Subject has been previously enrolled into the study. Urine specimen to be used for study purposes is from the first morning void. Subject has had an excision procedure within six weeks (42 days) of enrollment. The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Initial Enrollment<br>Initial enrollment of patients with history of bladder cancer | Device: Xpert Bladder Cancer Monitor<br>* in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer<br>|
| Longitudinal Cohort<br>Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient | Device: Xpert Bladder Cancer Monitor<br>* in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison to histology for positive or suspicious cystoscopy | Comparison to histology for positive or suspicious cystoscopy | Baseline = Subject Enrollment | 
| Comparison to histology for positive or suspicious cystoscopy | Comparison to histology for positive or suspicious cystoscopy | Follow up = 12 months from Subject Enrollment (Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison to UroVysion and urine cytology | Urovysion and urine cytology | Baseline = Subject Enrollment | 
| Comparison to UroVysion and urine cytology | Urovysion and urine cytology | Follow up = 12 months from Subject Enrollment (Baseline) |