Clinical trial · Observational
Molecular Biosensors for Detection of Bladder Cancer
Electro-Phage and Colorimetric Aptamer Sensors for Clinical Staging and Monitoring of Bladder Cancer
NCT02957370CI-TRIAL-00051035unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project focuses on developing specific and sensitive detectors of biomarker-based signatures associated with diagnosed and recurrent bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Diagnosed Urinary Bladder Neoplasms
- description
- 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
- label
- Non-Urinary Bladder Neoplasms
- description
- Patients being treated for hematuria will provide a negative control to provide data from testing for biomarkers in patients being treated for other diseases.
Primary outcomes (1)
- measure
- Urinary "Fingerprint" for Urinary Bladder Neoplasms
- timeFrame
- Four Years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (40)
- BACKGROUNDKay, 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.
- BACKGROUNDMohan 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
- BACKGROUNDArter 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
- BACKGROUNDArter 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
- BACKGROUNDDiaz 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
- BACKGROUNDDonavan 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
- BACKGROUNDWeiss 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
- BACKGROUNDYang 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.