New urine test for monitoring bladder cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Kyoto University Graduate School of Medicine
  Kyoto, Japan 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

Study contacts

• Principal investigator: Hideki Furuya, PhD — Cedars-Sinai Medical Center
• Study coordinator: Charles Rosser, MD
• Email: Charles.Rosser@cshs.org
• Phone: 310-423-5609

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.