Clincosm LogoSign in Get a demo

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Sponsor
Charles Rosser (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03193515
Collaborator
Fred Hutchinson Cancer Center (Other), University of Texas (Other), University of California, San Francisco (Other), Nonagen Bioscience Corporation (Industry), Kyoto University (Other)
300
Enrollment
4
Locations
84
Anticipated Duration (Months)
75
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
    Actual Study Start Date :
    Dec 30, 2016
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. [2 years]

      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 prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.

    Secondary Outcome Measures

    1. Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck. [2 years]

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

    Eligibility Criteria

    Criteria

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

    Inclusion Criteria

    Participants must be:

    • Age 18 years or older

    • Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance

    • Participants may be treated with adjuvant intravesical therapy

    • Willing and able to give written informed consent (see Appendix 1)

    • Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

    Exclusion Criteria:
    Participants must not:

    • Have had radical cystectomy

    • History of previous cancer (excluding bladder, 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 surveillance regimen

    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 San Francisco San Francisco California United States 94158
    3 UT Southwestern Medical Center at Dallas Dallas Texas United States 75390
    4 Kyoto University Graduate School of Medicine Kyoto Japan

    Sponsors and Collaborators

    • Charles Rosser
    • Fred Hutchinson Cancer Center
    • University of Texas
    • University of California, San Francisco
    • Nonagen Bioscience Corporation
    • Kyoto University

    Investigators

    • Principal Investigator: Hideki Furuya, PhD, Cedars-Sinai Medical Center
    • Study Director: Charles Rosser, Nonagen Bioscience Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles Rosser, Sponsor-Investigator, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT03193515
    Other Study ID Numbers:
    • Rosser-2015-6
    First Posted:
    Jun 20, 2017
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 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

    Study Results

    No Results Posted as of Apr 7, 2022