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

Running, not enrolling

Conditions studied: Bladder Cancer

In brief

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 gross hematuria.

Key facts

Study ID

NCT03193528

Run by

Cedars-Sinai Medical Center

People needed

450

Starts

2016-12-30

Expected to finish

2026-07-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of Rochester Medical Center — Rochester, New York, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Department of Urology, Nara Medical University — Nara, Japan
• Nara Precfecture Seiwa Medical Center — Nara, Japan

Full record on ClinicalTrials.gov

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