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

Sponsor
Charles Rosser (Other)
Overall Status
Recruiting
CT.gov ID
NCT03193541
Collaborator
Nonagen Bioscience Corporation (Industry), Nara Medical University (Other), University of California, Los Angeles (Other), University of Rochester (Other)
1,200
Enrollment
2
Locations
108
Anticipated Duration (Months)
600
Patients Per Site
5.6
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 microscopic hematuria.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic 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. Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [1 year]

    Secondary Outcome Measures

    1. Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 Nara Medical University Nara Japan

    Sponsors and Collaborators

    • Charles Rosser
    • Nonagen Bioscience Corporation
    • Nara Medical University
    • University of California, Los Angeles
    • University of Rochester

    Investigators

    • Study Director: Charles Rosser, MD, Nonagen Bioscience Corporation
    • Principal Investigator: Amit Gupta, MD, 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:
    NCT03193541
    Other Study ID Numbers:
    • Rosser-2015-8
    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