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

Sponsor
Charles Rosser (Other)
Overall Status
Recruiting
CT.gov ID
NCT03193528
Collaborator
Fred Hutchinson Cancer Center (Other), University of Texas (Other), Nara Medical University (Other), University of California, Los Angeles (Other), Nonagen Bioscience Corporation (Industry)
450
Enrollment
4
Locations
108
Anticipated Duration (Months)
112.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hematuria is the most common presentation of BCa with 22% of patients with gross 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 (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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
    Actual Study Start Date :
    Dec 30, 2016
    Anticipated Primary Completion Date :
    Dec 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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 cohort of 450 participants presenting with gross hematuria. [1 year]

    Secondary Outcome Measures

    1. To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort. [1 year]

    2. To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 years or older

    • Have documented or reported gross hematuria within 3 month of study enrollment

    • Willing and able to give written informed consent

    Exclusion Criteria (patients must not):

    • Have history of BCa

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 University of California Los Angeles Los Angeles California United States 90095
    3 UT Southwestern Medical Center at Dallas Dallas Texas United States 75390
    4 Department of Urology, Nara Medical University Nara Japan

    Sponsors and Collaborators

    • Charles Rosser
    • Fred Hutchinson Cancer Center
    • University of Texas
    • Nara Medical University
    • University of California, Los Angeles
    • Nonagen Bioscience Corporation

    Investigators

    • Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation
    • Principal Investigator: Amit Gupta, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles Rosser, Sponsor-Investigator, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT03193528
    Other Study ID Numbers:
    • Rosser-2015-7
    First Posted:
    Jun 20, 2017
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Hematuria

    Study Results

    No Results Posted as of Mar 21, 2022