Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
230 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-06-11
Study Completion Date
2022-04-30
Brief Summary
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This project focuses on developing specific and sensitive detectors of biomarker-based signatures associated with diagnosed and recurrent bladder cancer.
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Detailed Description
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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.
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.
Conditions
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Urinary Bladder Neoplasms
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of California, Irvine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jaime Landman, MD
Role: PRINCIPAL_INVESTIGATOR
UC Irvine
Locations
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University of California Irvine
Orange, California, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Kay, B. K. (1996) Table 15. M13 Stability and Instability, In Phage Display of Peptides and Proteins: A Laboratory Manual (Kay, B. K., Winter, J., McCafferty, J., Ed.), p 337, Academic Press, San Diego.
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Mohan K, Donavan KC, Arter JA, Penner RM, Weiss GA. Sub-nanomolar detection of prostate-specific membrane antigen in synthetic urine by synergistic, dual-ligand phage. J Am Chem Soc. 2013 May 22;135(20):7761-7. doi: 10.1021/ja4028082. Epub 2013 May 13.
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Arter JA, Diaz JE, Donavan KC, Yuan T, Penner RM, Weiss GA. Virus-polymer hybrid nanowires tailored to detect prostate-specific membrane antigen. Anal Chem. 2012 Mar 20;84(6):2776-83. doi: 10.1021/ac203143y. Epub 2012 Mar 7.
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Arter JA, Taggart DK, McIntire TM, Penner RM, Weiss GA. Virus-PEDOT nanowires for biosensing. Nano Lett. 2010 Dec 8;10(12):4858-62. doi: 10.1021/nl1025826. Epub 2010 Nov 1.
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Diaz JE, Yang LM, Lamboy JA, Penner RM, Weiss GA. Synthesis of a virus electrode for measurement of prostate specific membrane antigen. Methods Mol Biol. 2009;504:255-74. doi: 10.1007/978-1-60327-569-9_16.
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Yang LM, Diaz JE, McIntire TM, Weiss GA, Penner RM. Covalent virus layer for mass-based biosensing. Anal Chem. 2008 Feb 15;80(4):933-43. doi: 10.1021/ac071470f. Epub 2008 Jan 17.
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Zavada J, Zavadova Z, Zat'ovicova M, Hyrsl L, Kawaciuk I. Soluble form of carbonic anhydrase IX (CA IX) in the serum and urine of renal carcinoma patients. Br J Cancer. 2003 Sep 15;89(6):1067-71. doi: 10.1038/sj.bjc.6601264.
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Davis MI, Bennett MJ, Thomas LM, Bjorkman PJ. Crystal structure of prostate-specific membrane antigen, a tumor marker and peptidase. Proc Natl Acad Sci U S A. 2005 Apr 26;102(17):5981-6. doi: 10.1073/pnas.0502101102. Epub 2005 Apr 18.
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Hajduczki A, Majumdar S, Fricke M, Brown IA, Weiss GA. Solubilization of a membrane protein by combinatorial supercharging. ACS Chem Biol. 2011 Apr 15;6(4):301-7. doi: 10.1021/cb1001729. Epub 2011 Jan 14.
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Lunder, M., Bratkovic, T., Anderluh, G., Strukelj, B., and Kreft, S. (2008) Affinity ranking of phage-displayed peptides: Enzyme-linked immunosorbent assay versus surface plasmon resonance, Acta Chimica Slovenica 55, 233-235.
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Murase K, Morrison KL, Tam PY, Stafford RL, Jurnak F, Weiss GA. EF-Tu binding peptides identified, dissected, and affinity optimized by phage display. Chem Biol. 2003 Feb;10(2):161-8. doi: 10.1016/s1074-5521(03)00025-5.
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Liu J, Cao Z, Lu Y. Functional nucleic acid sensors. Chem Rev. 2009 May;109(5):1948-98. doi: 10.1021/cr030183i. No abstract available.
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Toma M, Loget G, Corn RM. Flexible Teflon nanocone array surfaces with tunable superhydrophobicity for self-cleaning and aqueous droplet patterning. ACS Appl Mater Interfaces. 2014 Jul 23;6(14):11110-7. doi: 10.1021/am500735v. Epub 2014 Apr 1.
Reference Type
BACKGROUND
Other Identifiers
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HS#2014-1758
Identifier Type: -
Identifier Source: org_study_id
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