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Observational Study for a New Bladder Cancer Test

This study is testing a new urine-based test called a multiplex ELISA assay. This test aims to improve how doctors find bladder cancer (BCa) that has come back, especially since current urine tests often miss early or low-grade cancers. If you are 18 or older and have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated with bladder-sparing techniques (or not yet treated) within the last 24 months, you might be able to join. The study will compare how well this new urine test works against cystoscopy (an examination where a small camera is inserted into the bladder) over two years. The study is currently observational, meaning it will watch and collect information without giving any specific treatments.

Study design
This is an observational study with a planned enrollment of 300 participants. It will compare the new urine test to cystoscopy.
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 2 years.

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

NCT03193515

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Recruiting
Not specifiedAges 18+Observational
Cedars-Sinai Medical Center
~300 participants
Updated 2026-02-04 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 4 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 2 years

Conditions

Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT03193515

Where you'd take part

This study runs at 4 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

  • Kyoto University Graduate School of Medicine

    Kyoto, Japanstudy coordinator listed

    Recruiting

  • University of California San Francisco

    San Francisco, Californiano site contact published

    Active, not recruiting

  • UT Southwestern Medical Center at Dallas

    Dallas, Texasno site contact published

    Active, not recruiting

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

Study leadership

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

Who to contact

Charles Rosser, MD
[email protected]
310-423-5609
Email the study team

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Eligibility criteria

Inclusion

Age 18 years or older
Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
Participants may be treated with adjuvant intravesical therapy
Willing and able to give written informed consent (see Appendix 1)
Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion

Have had radical cystectomy
History of previous cancer (excluding bladder, 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 surveillance regimen

What this trial measures

  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.2 years

    To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.