A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

What this study is about

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

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

Who to contact

Charles Rosser, MD · 310-423-5609 · charles.rosser@cshs.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03193541.