A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Last updated: January 30, 2023
Sponsor: Arquer Diagnostics Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT05508568
Arquer-US1
  • Ages > 22
  • All Genders

Study Summary

The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results will be compared with the gold standard cystoscopy and pathology of resected tissue.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have been diagnosed with NMIBC in the previous 2 years, and are attendingthe urology clinic for standard of care/routine monitoring cystoscopy
  • Patients 22 years of age or older
  • Patients who, in the opinion of the Investigator, are suitable for standard urologicalinvestigations as part of normal clinical practice
  • Patients who are, in the opinion of the Investigator, able to understand the purposeof the study and provide a full void urine specimen
  • Patients who are able to give voluntary, written informed consent to participate inthis study

Exclusion

Exclusion Criteria:

  • Patients with known active (symptomatic) calculi within the urino-genitary system
  • Patients who provide less than 10mL of full void urine
  • Patients undergoing active treatment for interstitial cystitis
  • Patients currently undergoing systemic chemotherapy or systemic immunotherapy orradiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
  • Patients who have previously been diagnosed with renal cancer, prostate cancer, MuscleInvasive Bladder cancer, an upper tract tumour, or CiS in the prostatic urethra
  • Patients who have had urological instrumentation to the urinary tract within 14 daysprior to the test
  • Male patients undergoing active treatment for prostatitis

Study Design

Total Participants: 650
Study Start date:
July 01, 2021
Estimated Completion Date:
April 30, 2023

Connect with a study center

  • The Urology Center of Colorado

    Denver, Colorado 80211
    United States

    Active - Recruiting

  • Advanced Urology Institute

    Daytona Beach, Florida 32114
    United States

    Active - Recruiting

  • First Urology

    Jeffersonville, Indiana 47130
    United States

    Active - Recruiting

  • Michigan Institute of Urology

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • New Jersey Urology

    Mount Laurel, New Jersey 08054
    United States

    Active - Recruiting

  • Associated Medical Professionals of NY

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Clinical Research Solutions

    Cleveland, Ohio 44130
    United States

    Active - Recruiting

  • MidLantic Urology

    Philadelphia, Pennsylvania 19004
    United States

    Active - Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Virginia Urology Center

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Urology of Virginia

    Virginia Beach, Virginia 23462
    United States

    Active - Recruiting

  • Spokane Urology

    Spokane, Washington 99202
    United States

    Active - Recruiting

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