A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
NCT ID: NCT03193541
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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RECRUITING
900 participants
OBSERVATIONAL
2016-12-30
2029-02-28
Brief Summary
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Detailed Description
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We propose to improve 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.
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 microscopic 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)
* 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)
18 Years
90 Years
ALL
No
Sponsors
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Nonagen Bioscience Corporation
INDUSTRY
Nara Medical University
OTHER
University of California, Los Angeles
OTHER
University of Rochester
OTHER
National Cancer Institute (NCI)
NIH
University of Texas, Southwestern Medical Center at Dallas
OTHER
VA Long Beach Healthcare System
FED
Nara Prefecture Seiwa Medical Center
UNKNOWN
University of Hawaii Cancer Research Center
OTHER
Fred Hutchinson Cancer Center
OTHER
Hoag Memorial Hospital Presbyterian
OTHER
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Charles Rosser
Professor
Principal Investigators
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Charles Rosser, MD
Role: STUDY_DIRECTOR
Nonagen Bioscience Corporation
Hideki Furuya, PhD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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VA Long Beach Healthcare System
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of Rochester Medical Center
Rochester, New York, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Nara Prefecture Seiwa Medical Center
Nara, Nara, Japan
Nara Medical University
Nara, , Japan
Countries
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Central Contacts
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Facility Contacts
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Satoshi Anai, MD
Role: primary
Takuto Shimizu, MD
Role: primary
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.
Other Identifiers
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Rosser-2015-8
Identifier Type: -
Identifier Source: org_study_id
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