Molecular Biosensors for Detection of Bladder Cancer

The focus of this research is to discover urinary biomarker(s) that is distinct to bladder
cancer, while developing molecular sensors that can detect the urinary anomalies. By applying
in vitro selection techniques, both entities (biomarker discovery and sensor development)
will be done simultaneously.

All patients with bladder cancer diagnosis undergoing transurethral resection bladder tumor
(TURBT), those under surveillance for bladder cancer and patients presenting with microscopic
and visible (gross) hematuria will be invited to participate in the study. Patients will
undergo a standard of care evaluation as previously described (upper urinary tract imaging,
cystouretheroscopy and urine testing with urinalysis, culture and cytology).

Urine samples (10 mL) for the study will be collected prior to initial cystoscopy and/or
TURBT. The specimen will be barcoded and tracked by the UC Irvine Health software. Barcode
encoding will ensure that the identity of the patient and his/her clinical outcome will not
be available to the researchers for a blinded trial.

Patients involved in this study will only provide his or her urine for fundamental science
research; beyond that, standard of care will be provided for the patients. With respect to
the collected urine, it will be used as a medium for phage and aptamer production in an in
vitro fashion. The generated molecular probes will be use to assess and elucidate biomarkers
present for individuals with bladder cancer.

100 patients who are being monitored for bladder cancer will be the experimental group to
test the electro-phage and aptamer approach to following bladder cancer biomarkers.
Additionally, 100 patients being treated for hematuria will provide a negative control to
provide data from testing for biomarkers in patients being treated for other diseases.

Inclusion Criteria:

- Patients ≥18 years old

- Patients with diagnosed bladder cancer, undergoing transurethral resection bladder
tumor (TRUBT), or under surveillance (within 2 years) for recurrent bladder cancer

- Patients with microscopic and macroscopic hematuria

- Willing and able to consent

Exclusion Criteria:

- Patients <18 years old

- Patients who are not able to give consent for study

- Patients with urinary diversions

- Patients who have had a recent percutaneous or endoscopic procedures for upper tract
diseases such as stones or other conditions

- Patients who have ureteral stents placed for upper urinary tract obstruction

- Patients with recent trauma in kidney, bladder or perineal area, which may be the
cause of hematuria

- Minors will be excluded from this study because ureteral stent placement is usually
performed in adult patients. Additionally, minors are treated at CHOC Hospital, and
not UCIMC.

- Women who are pregnant are excluded from this study since surgical treatments are not
typically performed on pregnant women. Watchful waiting is the preferred approach for
pregnant women. Furthermore, this research does not directly benefit the pregnant
woman or fetus, and biomedical knowledge can be obtained using subjects who are not
pregnant. Therefore, per the federal regulations, pregnant women will be excluded from
this study.