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

Study ID
STU 092015-004

Study Sites

  • Clements University Hospital

Contact
Allison Beaver
214/645-8788
ALLISON.BEAVER@UTSouthwestern.edu

Principal Investigator
Yair Lotan, M.D.

Summary

This is a multi-center, prospective study with approximately 20 clinical sites located in and outside the united States. The study duration is expected to include approximately eight months of enrollment, but shall depend upon the observed disease prevalence relative to the study sample size. in addition, all anticipatory Positive recurrence subjects, as well as a subset of recurrence subjects with a negative Xpert Bladder cancer monitor result and who are considered disease negative at the initial visit, shall be entered into the longitudinal cohort. The Longitudinal Cohort shall be followed for a minimum of 12 months from the initial enrollment date to assess disease outcome over time.

Participant Eligibility

The subject shall meet all of the following criteria in order to be considered eligible for
enrollment:
Symptomatic 3.7.1.1 Cohort

* Subject is 18 years or older and has provided documented informed consent as required
by the reviewing Institutional Review Board (IRB) or Ethics Committee (EC) and, for
California only, signed the Experimental Subjects Bill of Rights.

* Subject has presented with subject-reported macroscopic (gross) or diagnosed with
microscopic hematuria within 12 weeks of the date of enrollment.

* At the time of the enrollment visit, the subject completes a standard of care cystoscopy.

* Subject has agreed and is able to provide at least 60 mL of voided urine for study
purposes at the enrollment visit.

* Subject has agreed to a bladder biopsy specimen taken during a positive or suspicious
cystoscopy.
NOTE: If the subject is scheduled for a TURB procedure or other excision procedure due
to a positive cystoscopy, biopsy data from this procedure may be used in lieu of a biopsy
during cystoscopy. The excision procedure must be completed within 6 weeks of the
cystoscopy procedure or the subject shall be excluded.
3.7.1.2 Recurrence Cohort

* Subject is 18 years or older and has provided documented informed consent as required
by the reviewing Institutional Review Board (IRB) or Ethics Committee (EC) and, for
California only, signed the Experimental Subjects Bill of Rights.

* Subject has had an initial diagnosis or recurrence of existing urothelial carcinoma within
12 months of the date of enrollment.

* At the time of the enrollment visit, the subject completes a standard of care cystoscopy.

* Subject has agreed and is able to provide at least 60 mL of voided urine for study
purposes at the enrollment visit.

* Subject has agreed to a bladder biopsy specimen taken during a positive or suspicious
cystoscopy.
NOTE: If the subject is scheduled for a TURB procedure or other excision procedure due
to a positive cystoscopy, biopsy data from this procedure may be used in lieu of a biopsy
during cystoscopy. The excision procedure must be completed within 6 weeks of the
cystoscopy procedure or the subject shall be excluded.

* 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 following enrollment
if criteria are met to be entered into the Longitudinal Cohort (Section 3.7.1.3).
3.7.1.3 Longitudinal Cohort

* All recurrence subjects considered Anticipatory Positive at the initial visit.

* A simple random sample of recurrence subjects with a negative Xpert Bladder Assay
result and who are considered disease negative at the initial visit.
NOTE: To ensure equal numbers across these two strata, a random recurrence subject who is
considered disease negative at the initial visit shall be selected to participate in the
Longitudinal Cohort for each anticipatory positive identified at the initial visit.