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Recruiting NCT03193541

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

— Observational Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.

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.

Primary outcome measures

  • Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [Time frame: 1 year]
Secondary outcome measures (1)
  • Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • VA Long Beach Healthcare System — Long Beach
  • Cedars-Sinai Medical Center — Los Angeles
  • UCLA Medical Center — Los Angeles
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • University of Rochester Medical Center — Rochester
  • UT Southwestern Medical Center at Dallas — Dallas
Japan · 2 centers
  • Nara Prefecture Seiwa Medical Center — Nara
  • Nara Medical University — Nara

Publications

  • Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9;24(1):791. doi: 10.1186/s1 PMID 42106837
  • 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. PMID 38167321
  • 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. PMID 38045238

Identifiers

NCT: NCT03193541 · Rosser-2015-8 · R01CA198887

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗