Molecular Biosensors for Detection of Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT02957370|
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : October 11, 2018
|Condition or disease|
|Urinary Bladder Neoplasms|
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.
|Study Type :||Observational|
|Estimated Enrollment :||230 participants|
|Official Title:||Electro-Phage and Colorimetric Aptamer Sensors for Clinical Staging and Monitoring of Bladder Cancer|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2021|
Diagnosed Urinary Bladder Neoplasms
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
Non-Urinary Bladder Neoplasms
Patients being treated for hematuria will provide a negative control to provide data from testing for biomarkers in patients being treated for other diseases.
- Urinary "Fingerprint" for Urinary Bladder Neoplasms [ Time Frame: Four Years ]A representative sequence from each class of the selected population will be synthesized and the fundamental properties for each aptamer sequences such as dissociation constant, switching performance, sensitivity, selectivity, and detection range will be measured using a Förster resonance energy transfer (FRET) system.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957370
|Contact: Victor B Huynh, BSemail@example.com|
|United States, California|
|University of California Irvine||Recruiting|
|Orange, California, United States, 92840|
|Contact: Victor Huynh, BS 714-456-8176 firstname.lastname@example.org|
|Principal Investigator:||Jaime Landman, MD||UC Irvine|