Evaluation of the Xpert Bladder Assay for Monitoring of Recurrence in Bladder Cancer Patients and Detection of Bladder Cancer in Symptomatic Patients.

Summary

This is a multi-center, prospective, longitudinal study with approximately 12-20 sites. The study duration is expected to be approximately 4 months. For Monitoring of Recurrence in Patients with a History of Bladder Cancer Subjects previously diagnosed with urothelial bladder cancer within the preceding 9 months including those undergoing BCG intravesical therapy will be recruited until the sample size of approximately 300 (or ~75 cystoscopy positive cases with histology confirmation where available) is reached. For Detection of Bladder Cancer in Symptomatic Patients (Patients with Hematuria) Subjects with confirmed presentation of microscopic or gross hematuria within the
3 months prior to the study enrollment visit will be recruited until the sample size of ~400 subjects (or ~40 cystoscopy positive cases with histology confirmation where available) is reached. In this study, voided urine specimens shall be collected from bladder cancer patients during a routine cystoscopy follow-up visit or collected from symptomatic patients suspected of having bladder cancer before a cystoscopy procedure. The voided urine shall support split-specimen analysis by the Xpert Bladder Assay, cytology, and UroVysion. The cytology result is for information purposes only and will not be included in the data analyses for the primary or secondary study objectives. Any biopsy specimens taken during cystoscopy or a subsequent TURB procedure within 6 weeks at initial or follow-up visits shall be subject to both local pathology review for patient management purposes and later, retrospective Central Pathology Laboratory review for study purposes only. Biopsy collection procedures shall seek to acquire sufficient tissue for the local pathology laboratory to prepare 2 adjacent slides of each biopsy to support the later Central Pathology Laboratory review or alternatively if the site prefers not to prepare extra slides, after the local pathologist[Right Quote]s review the site shall loan the slide(s) to Central Pathology Laboratory for review. Xpert Bladder Assay performance characteristics will be established relative to cystoscopy followed by histology for confirmation of positive or suspicious cystoscopies, the SOC for monitoring of disease recurrence.

Participant Eligibility

To be enrolled in this study, the following inclusion criteria must be met:

* Subject is 18 years or older has provided documented informed consent as required
by the reviewing IRB or HREC and, for California only, signed the Experimental
Subjects Bill of Rights.

* Subject agreed to provide >60 mL voided urine before cystoscopy.
For Monitoring of Recurrence in Patients with a History of Bladder Cancer ONLY

* Subject meets study definition of a bladder cancer patient (i.e. patient was diagnosed
with urothelial bladder cancer within the 9 months preceding the study enrollment
visit).
For Detection of Bladder Cancer in Symptomatic Patients (with Hematuria) ONLY

* Subjects with confirmed presentation of microscopic or gross hematuria within 3
months of study enrollment