Molecular Biosensors for Detection of Bladder Cancer

NCT02957370 | Unknown

• 1 other identifier: HS#2014-1758
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Urinary "Fingerprint" for Urinary Bladder Neoplasms

  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.

  Four Years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at the University of California, Irvine Medical Center Douglas Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine

Orange, California, 92840, United States

RECRUITING

Related Publications (40)

• 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.

  BACKGROUND

• 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.

  PMID: 23614709 BACKGROUND

• 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.

  PMID: 22339784 BACKGROUND

• 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.

  PMID: 21038915 BACKGROUND

• 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.

  PMID: 19159102 BACKGROUND

• Donavan KC, Arter JA, Weiss GA, Penner RM. Virus-poly(3,4-ethylenedioxythiophene) biocomposite films. Langmuir. 2012 Aug 28;28(34):12581-7. doi: 10.1021/la302473j. Epub 2012 Aug 16.

  PMID: 22856875 BACKGROUND

• Weiss GA, Penner RM. The Promise of Phage Display: Customized Affinity and Specificity. Anal Chem. 2008 May 1;80(9):3082-3089. doi: 10.1021/ac086009h. No abstract available.

  PMID: 28193009 BACKGROUND

• Yang LM, Diaz JE, McIntire TM, Weiss GA, Penner RM. Direct electrical transduction of antibody binding to a covalent virus layer using electrochemical impedance. Anal Chem. 2008 Aug 1;80(15):5695-705. doi: 10.1021/ac8008109. Epub 2008 Jul 1.

  PMID: 18590279 BACKGROUND

• Yang LM, Tam PY, Murray BJ, McIntire TM, Overstreet CM, Weiss GA, Penner RM. Virus electrodes for universal biodetection. Anal Chem. 2006 May 15;78(10):3265-70. doi: 10.1021/ac052287u.

  PMID: 16689525 BACKGROUND

• Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.

  PMID: 10647931 BACKGROUND

• Wallace TJ, Torre T, Grob M, Yu J, Avital I, Brucher B, Stojadinovic A, Man YG. Current approaches, challenges and future directions for monitoring treatment response in prostate cancer. J Cancer. 2014 Jan 1;5(1):3-24. doi: 10.7150/jca.7709.

  PMID: 24396494 BACKGROUND

• Romero Otero J, Garcia Gomez B, Campos Juanatey F, Touijer KA. Prostate cancer biomarkers: an update. Urol Oncol. 2014 Apr;32(3):252-60. doi: 10.1016/j.urolonc.2013.09.017. Epub 2014 Feb 1.

  PMID: 24495450 BACKGROUND

• Guan W, Duan X, Reed MA. Highly specific and sensitive non-enzymatic determination of uric acid in serum and urine by extended gate field effect transistor sensors. Biosens Bioelectron. 2014 Jan 15;51:225-31. doi: 10.1016/j.bios.2013.07.061. Epub 2013 Aug 7.

  PMID: 23968728 BACKGROUND

• 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.

  PMID: 18198846 BACKGROUND

• Brigati JR, Petrenko VA. Thermostability of landscape phage probes. Anal Bioanal Chem. 2005 Jul;382(6):1346-50. doi: 10.1007/s00216-005-3289-y. Epub 2005 Jun 18.

  PMID: 15965686 BACKGROUND

• Nanduri V, Sorokulova IB, Samoylov AM, Simonian AL, Petrenko VA, Vodyanoy V. Phage as a molecular recognition element in biosensors immobilized by physical adsorption. Biosens Bioelectron. 2007 Jan 15;22(6):986-92. doi: 10.1016/j.bios.2006.03.025. Epub 2006 May 30.

  PMID: 16730970 BACKGROUND

• 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.

  PMID: 12966427 BACKGROUND

• Huang S, Rhee E, Patel H, Park E, Kaswick J. Urinary NMP22 and renal cell carcinoma. Urology. 2000 Feb;55(2):227-30. doi: 10.1016/s0090-4295(99)00401-x.

  PMID: 10688084 BACKGROUND

• Kaya K, Ayan S, Gokce G, Kilicarslan H, Yildiz E, Gultekin EY. Urinary nuclear matrix protein 22 for diagnosis of renal cell carcinoma. Scand J Urol Nephrol. 2005;39(1):25-9. doi: 10.1080/00365590410002500.

  PMID: 15764267 BACKGROUND

• Myers-Irvin JM, Landsittel D, Getzenberg RH. Use of the novel marker BLCA-1 for the detection of bladder cancer. J Urol. 2005 Jul;174(1):64-8. doi: 10.1097/01.ju.0000162022.36772.a4.

  PMID: 15947579 BACKGROUND

• van Rhijn BW, van der Poel HG, van der Kwast TH. Urine markers for bladder cancer surveillance: a systematic review. Eur Urol. 2005 Jun;47(6):736-48. doi: 10.1016/j.eururo.2005.03.014. Epub 2005 Mar 23.

  PMID: 15925067 BACKGROUND

• Majumdar S, Hajduczki A, Mendez AS, Weiss GA. Phage display of functional, full-length human and viral membrane proteins. Bioorg Med Chem Lett. 2008 Nov 15;18(22):5937-40. doi: 10.1016/j.bmcl.2008.07.051. Epub 2008 Jul 17.

  PMID: 18667306 BACKGROUND

• Levin AM, Weiss GA. Optimizing the affinity and specificity of proteins with molecular display. Mol Biosyst. 2006 Jan;2(1):49-57. doi: 10.1039/b511782h. Epub 2005 Nov 8.

  PMID: 16880922 BACKGROUND

• 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.

  PMID: 15837926 BACKGROUND

• 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.

  PMID: 21192634 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12618188 BACKGROUND

• Weiss GA, Watanabe CK, Zhong A, Goddard A, Sidhu SS. Rapid mapping of protein functional epitopes by combinatorial alanine scanning. Proc Natl Acad Sci U S A. 2000 Aug 1;97(16):8950-4. doi: 10.1073/pnas.160252097.

  PMID: 10908667 BACKGROUND

• Avrantinis SK, Stafford RL, Tian X, Weiss GA. Dissecting the streptavidin-biotin interaction by phage-displayed shotgun scanning. Chembiochem. 2002 Dec 2;3(12):1229-34. doi: 10.1002/1439-7633(20021202)3:123.0.CO;2-X.

  PMID: 12465031 BACKGROUND

• Mohan K, Weiss GA. Dual genetically encoded phage-displayed ligands. Anal Biochem. 2014 May 15;453:1-3. doi: 10.1016/j.ab.2014.02.025. Epub 2014 Mar 4.

  PMID: 24607794 BACKGROUND

• Levin AM, Murase K, Jackson PJ, Flinspach ML, Poulos TL, Weiss GA. Double barrel shotgun scanning of the caveolin-1 scaffolding domain. ACS Chem Biol. 2007 Jul 20;2(7):493-500. doi: 10.1021/cb700055t. Epub 2007 Jun 29.

  PMID: 17602618 BACKGROUND

• Levin AM, Coroneus JG, Cocco MJ, Weiss GA. Exploring the interaction between the protein kinase A catalytic subunit and caveolin-1 scaffolding domain with shotgun scanning, oligomer complementation, NMR, and docking. Protein Sci. 2006 Mar;15(3):478-86. doi: 10.1110/ps.051911706. Epub 2006 Feb 1.

  PMID: 16452625 BACKGROUND

• Nutiu R, Li Y. In vitro selection of structure-switching signaling aptamers. Angew Chem Int Ed Engl. 2005 Feb 4;44(7):1061-1065. doi: 10.1002/anie.200461848. No abstract available.

  PMID: 15643624 BACKGROUND

• Oh SS, Plakos K, Lou X, Xiao Y, Soh HT. In vitro selection of structure-switching, self-reporting aptamers. Proc Natl Acad Sci U S A. 2010 Aug 10;107(32):14053-8. doi: 10.1073/pnas.1009172107. Epub 2010 Jul 26.

  PMID: 20660786 BACKGROUND

• Tuerk C, Gold L. Systematic evolution of ligands by exponential enrichment: RNA ligands to bacteriophage T4 DNA polymerase. Science. 1990 Aug 3;249(4968):505-10. doi: 10.1126/science.2200121.

  PMID: 2200121 BACKGROUND

• Ellington AD, Szostak JW. In vitro selection of RNA molecules that bind specific ligands. Nature. 1990 Aug 30;346(6287):818-22. doi: 10.1038/346818a0.

  PMID: 1697402 BACKGROUND

• 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.

  PMID: 19301873 BACKGROUND

• Zhao W, Ali MM, Aguirre SD, Brook MA, Li Y. Paper-based bioassays using gold nanoparticle colorimetric probes. Anal Chem. 2008 Nov 15;80(22):8431-7. doi: 10.1021/ac801008q. Epub 2008 Oct 11.

  PMID: 18847216 BACKGROUND

• Wood JB, Szyndler MW, Halpern AR, Cho K, Corn RM. Fabrication of DNA microarrays on polydopamine-modified gold thin films for SPR imaging measurements. Langmuir. 2013 Aug 27;29(34):10868-73. doi: 10.1021/la402425n. Epub 2013 Aug 15.

  PMID: 23902428 BACKGROUND

• 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.

  PMID: 24654844 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jaime Landman, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor B Huynh, BS

CONTACT

714-456-8176; vbhuynh@uci.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: November 7, 2016
• Study Start: June 11, 2015
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 2, 2021

Record last verified: 2021-04

Locations

US (1)