findmyKOL
Clinical trialNCT05508568UnknownObservational

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

SponsorArquer Diagnostics LtdEnrollment650Bladder Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • the Urology Center of Colorado

    Denver, Colorado, United States

    Larry Karsh, MD
    Recruiting
  • Advanced Urology Institute

    Daytona Beach, Florida, United States

    Martin K. Deneen, MD
    Recruiting
  • First Urology

    Jeffersonville, Indiana, United States

    James Bailen, MD
    Recruiting
  • Michigan Institute of Urology

    Troy, Michigan, United States

    Jason Hafron, MD
    Recruiting
  • New Jersey Urology

    Mount Laurel, New Jersey, United States

    Louis Keeler, MD
    Recruiting
  • Associated Medical Professionals of Ny

    Syracuse, New York, United States

    Christopher Pieczonka, MD
    Recruiting
  • Clinical Research Solutions

    Cleveland, Ohio, United States

    Lawrence A. Gervasi, MD
    Recruiting
  • Midlantic Urology

    Philadelphia, Pennsylvania, United States

    Laurence Belkoff, MD
    Recruiting
  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, United States

    Neal Shore, MD
    Recruiting
  • Urology San Antonio

    San Antonio, Texas, United States

    Jose De La Cerda, MD
    Recruiting
  • Virginia Urology Center

    Richmond, Virginia, United States

    Eugene Kramolowsky, MD
    Recruiting
  • Urology of Virginia

    Virginia Beach, Virginia, United States

    Michael Williams, MD
    Recruiting
  • Spokane Urology

    Spokane, Washington, United States

    Raymond Lance, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Jul 2021
Primary completion
1 Jan 2023
Completion
30 Apr 2023
Last update posted
1 Feb 2023
Registered enrollment
650
Registry id
NCT05508568
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.