A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
NCT ID: NCT03193528
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
450 participants
OBSERVATIONAL
2016-12-30
2026-07-31
Brief Summary
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Detailed Description
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Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Have documented or reported gross hematuria within 3 month of study enrollment
* Willing and able to give written informed consent
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
University of Texas
OTHER
Nara Medical University
OTHER
University of California, Los Angeles
OTHER
Nonagen Bioscience Corporation
INDUSTRY
National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Nara Prefecture Seiwa Medical Center
UNKNOWN
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Principal Investigators
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Charles Rosser, MD
Role: STUDY_DIRECTOR
Nonagen Bioscience Corporation
Hideki Furuya, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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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
Countries
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References
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Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Rosser-2015-7
Identifier Type: -
Identifier Source: org_study_id
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