New urine test for bladder cancer detection in patients with blood in urine
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
This study is testing a new urine test to see if it can better detect bladder cancer in people who have blood in their urine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT03193528 on ClinicalTrials.gov |
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 in urine samples from patients experiencing gross hematuria. Hematuria is a common symptom of BCa, but current urine tests often miss low-grade or early-stage cancers. By improving the accuracy of urine-based diagnostics, the study seeks to reduce the need for invasive bladder examinations. Participants will be evaluated based on their hematuria status and will provide urine samples for analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced gross hematuria within the last three months.
Not a fit: Patients with a history of bladder cancer or other specified urinary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this assay could lead to earlier and more accurate detection of bladder cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored urine-based assays for bladder cancer detection, but this specific multiplex ELISA approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Have documented or reported gross hematuria within 3 month of study enrollment * Willing and able to give written informed consent Exclusion Criteria (patients must not): * Have history of BCa * History of previous cancer (excluding 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 hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Where this trial is running
Los Angeles, California and 5 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, 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)
- Department of Urology, Nara Medical University — Nara, Japan (Recruiting)
- Nara Precfecture Seiwa Medical Center — Nara, Japan (Recruiting)
Study contacts
- Principal investigator: Hideki Furuya, MD — Cedars-Sinai Medical Center
- Study coordinator: Charles Rosser, MD
- Email: charles.rosser@cshs.org
- Phone: 310-423-5609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.