New urine test for monitoring bladder cancer patients

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

This study is testing a new urine test to see if it can better detect recurring bladder cancer in patients, so they might avoid more invasive procedures.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT03193515 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance the non-invasive detection of recurrent bladder cancer by validating a novel multiplex ELISA assay that targets a specific diagnostic signature in voided urine samples. Current methods, such as voided urinary cytology, have significant limitations, particularly in detecting low-grade or early-stage bladder cancer. By improving detection rates, this study seeks to reduce the need for invasive cystoscopy procedures in patients under surveillance for bladder cancer recurrence. Participants will include individuals with a history of non-muscle invasive or muscle invasive bladder cancer who are undergoing regular monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of bladder cancer who are currently under surveillance.

Not a fit: Patients who have undergone radical cystectomy or have a history of other cancers within the past three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this assay could provide a more accurate and less invasive method for monitoring bladder cancer recurrence, improving patient comfort and outcomes.

How similar studies have performed: While there have been various approaches to bladder cancer detection, this specific multiplex ELISA assay represents a novel method that has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria

Participants must be:

* Age 18 years or older
* Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
* Participants may be treated with adjuvant intravesical therapy
* Willing and able to give written informed consent (see Appendix 1)
* Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

* Have had radical cystectomy
* History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
* Have a known active urinary tract infection or urinary retention
* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwise repeat.
* Have ureteral stents, nephrostomy tubes or bowel interposition
* Have recent genitourinary instrumentation (within 10 days prior to signing consent)
* Be unable or unwilling to complete the surveillance regimen

Where this trial is running

Los Angeles, California and 3 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Active_not_recruiting)
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States (Active_not_recruiting)
• Kyoto University Graduate School of Medicine — Kyoto, Japan (Recruiting)

Study contacts

• Principal investigator: Hideki Furuya, PhD — Cedars-Sinai Medical Center
• Study coordinator: Charles Rosser, MD

Conditions Bladder Cancer