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Urinary Bladder NeoplasmsNCT02957370

Molecular Biosensors for Detection of Bladder Cancer

An observational study of Urinary Bladder Neoplasms, run by University of California, Irvine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
How many people
230 participants
Where
1 siteUnited States
Study dates
11 Jun 2015to Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Victor B Huynh, BS contact

714-456-8176

vbhuynh@uci.edu

United States1 site, 1 recruiting

  • University of California Irvine

    Orange, California, 92840

    Victor Huynh, BS, 714-456-8176, vbhuynh@uci.edu

    Recruiting

Other trials in United States

About this study

Official title: Electro-Phage and Colorimetric Aptamer Sensors for Clinical Staging and Monitoring of Bladder Cancer

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

Read the 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.

Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02957370
Study groupRoleWhat they receive
Diagnosed Urinary Bladder NeoplasmsPatients 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 NeoplasmsPatients being treated for hematuria will provide a negative control to provide data from testing for biomarkers in patients being treated for other diseases.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Four Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study start11 Jun 2015
  3. Primary completionApr 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02957370
Sponsor's protocol ID
HS#2014-1758
Status last verified
Apr 2021
First submitted
10 Jun 2015
Last updated
2 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

    PubMed 23614709

  • 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.

    PubMed 22339784

  • 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.

    PubMed 21038915

  • 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.

    PubMed 19159102

  • 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.

    PubMed 22856875

  • 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.

    PubMed 28193009

  • 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.

    PubMed 18590279

  • 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.

    PubMed 16689525

  • 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.

    PubMed 10647931

  • 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.

    PubMed 24396494

  • 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.

    PubMed 24495450

  • 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.

    PubMed 23968728

  • 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.

    PubMed 18198846

  • 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.

    PubMed 15965686

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Bladder Neoplasms, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Victor B Huynh, BS (714-456-8176, vbhuynh@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary "Fingerprint" for Urinary Bladder Neoplasms (time frame: Four Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02957370, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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