New urine test for detecting bladder cancer in patients with blood in urine
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic 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 | 900 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 8 sites (Long Beach, California and 7 other locations) |
| Trial ID | NCT03193541 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 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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have documented microscopic 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 approach could lead to earlier and more accurate detection of bladder cancer, reducing the need for invasive procedures.
How similar studies have performed: Other studies have explored urine-based assays for bladder cancer detection, but this multiplex ELISA approach is a novel attempt to improve diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Long Beach, California and 7 other locations
- 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)
- Nara Prefecture Seiwa Medical Center — Nara, Nara, Japan (Recruiting)
- Nara Medical University — Nara, Japan (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
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.