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

Recruiting now

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 microscopic hematuria.

Key facts

Study ID

NCT03193541

Run by

Cedars-Sinai Medical Center

People needed

900

Starts

2016-12-30

Expected to finish

2029-02-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• 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 is running

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

Full record on ClinicalTrials.gov

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