Evaluating a New Test for Bladder Cancer in Patients with Microscopic Hematuria

This study is testing a new way to detect bladder cancer (BCa) non-invasively. Researchers are evaluating a multiplex ELISA assay, which is a type of lab test, using urine samples from people who have microscopic hematuria (blood in the urine that can only be seen under a microscope). The goal is to see if this new test can accurately identify bladder cancer, which is currently often missed by other urine tests. The study aims to enroll about 900 participants aged 18 to 90 years old who have had microscopic hematuria within the last three months and are willing to give their consent. Success will be measured by how well the test's sensitivity and specificity (its ability to correctly identify those with and without bladder cancer) are confirmed by a cystoscopy (an invasive procedure where a camera is inserted into the bladder) after one year. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will observe and collect data without providing any specific intervention. It aims to enroll approximately 900 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures the test's accuracy, will be assessed at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03193541

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

Recruiting
Not specifiedAges 18–90Observational
Cedars-Sinai Medical Center
~900 participants
Updated 2026-02-04 on ClinicalTrials.gov

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
Measured over 1 year
Bladder Cancer

NCT03193541

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, Californiastudy coordinator listed

    Recruiting

  • UCLA Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • University of Rochester Medical Center

    Rochester, New Yorkstudy coordinator listed

    Recruiting

  • UT Southwestern Medical Center at Dallas

    Dallas, Texasstudy coordinator listed

    Recruiting

  • VA Long Beach Healthcare System

    Long Beach, Californiastudy coordinator listed

    Recruiting

  • Nara Medical University

    Nara, Japanno site contact published

    Recruiting

  • Nara Prefecture Seiwa Medical Center

    Nara, Nara, Japanno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Charles Rosser, MD · STUDY_DIRECTOR · Nonagen Bioscience Corporation
  • Hideki Furuya, PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

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

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)
  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.1 year