Clinical trial NCT02957370: Molecular Biosensors for Detection of Bladder Cancer
Official title: Electro-Phage and Colorimetric Aptamer Sensors for Clinical Staging and Monitoring of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder Neoplasms
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited at the University of California, Irvine Medical Center Douglas Hospital.

Brief summary: This project focuses on developing specific and sensitive detectors of biomarker-based signatures associated with diagnosed and recurrent bladder cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary "Fingerprint" for Urinary Bladder Neoplasms
timeFrame: Four Years
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Jaime Landman, MD
role: PRINCIPAL_INVESTIGATOR
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