New urine test for detecting bladder cancer in patients with blood in urine

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 study aims to enhance the non-invasive detection of bladder cancer (BCa) by validating a multiplex ELISA assay that targets a diagnostic signature associated with BCa in urine samples from patients exhibiting microscopic hematuria. Hematuria is a common symptom of BCa, but existing urine tests often miss early-stage or low-grade cancers, leading to unnecessary invasive procedures. By focusing on patients with documented microscopic hematuria, the study seeks to improve diagnostic accuracy and reduce the need for invasive bladder examinations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Have documented or reported microscopic hematuria within 3 month of study enrollment
* Willing and able to give written informed consent

Exclusion Criteria (participants must not):

* Have history of BCa
* History of previous cancer (excluding basal and squamous cell skin cancer)
* 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)
* 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 hematuria evaluation (i.e., cystoscopy and upper tract imaging)

Where it's running

• VA Long Beach Healthcare System
  Long Beach, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• University of Rochester Medical Center
  Rochester, New York, United States Recruiting
• UT Southwestern Medical Center at Dallas
  Dallas, Texas, United States 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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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.