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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
Sponsor:
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine

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

Condition or disease
Urinary Bladder Neoplasms

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.

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort
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.



Primary Outcome Measures :
  1. 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
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited at the University of California, Irvine Medical Center Douglas Hospital.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Victor B Huynh, BS 714-456-8176 vbhuynh@uci.edu

Locations
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United States, California
University of California Irvine Recruiting
Orange, California, United States, 92840
Contact: Victor Huynh, BS    714-456-8176    vbhuynh@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Jaime Landman, MD UC Irvine
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.
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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Responsible Party: Jaime Landman, Dr. Jaime Landman M.D., University of California, Irvine
ClinicalTrials.gov Identifier: NCT02957370    
Other Study ID Numbers: HS#2014-1758
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases