Recruiting

Bladder Cancer

Sponsor:

UCLA

Code:

NCT02957370

Conditions

Urinary Bladder Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02957370

Start date

Jun 11, 2015

Status verified date

Apr, 2021

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Urinary "Fingerprint" for Urinary Bladder Neoplasms [ Time Frame: Four Years ]

Central Contacts and Locations

Central contacts

Victor B Huynh, BS

714-456-8176vbhuynh@uci.edu

Locations

University of California Irvine

Recruiting

Orange, California, United States, 92840

Contacts

Victor Huynh, BS

714-456-8176vbhuynh@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Apr 2, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2021-04-02.