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

January 30, 2023 updated by: Arquer Diagnostics Ltd
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80211
        • Recruiting
        • The Urology Center of Colorado
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Advanced Urology Institute
        • Principal Investigator:
          • Martin K. Deneen, MD
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Recruiting
        • First Urology
        • Principal Investigator:
          • James Bailen, MD
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology
        • Principal Investigator:
          • Jason Hafron, MD
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • New Jersey Urology
        • Principal Investigator:
          • Louis Keeler, MD
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals of Ny
        • Principal Investigator:
          • Christopher Pieczonka, MD
    • Ohio
      • Cleveland, Ohio, United States, 44130
        • Recruiting
        • Clinical Research Solutions
        • Principal Investigator:
          • Lawrence A. Gervasi, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology
        • Principal Investigator:
          • Laurence Belkoff, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio
        • Principal Investigator:
          • Jose De La Cerda, MD
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • Virginia Urology Center
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia
        • Principal Investigator:
          • Michael Williams, MD
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology
        • Principal Investigator:
          • Raymond Lance, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

Description

Inclusion Criteria:

  • Patients who have been diagnosed with NMIBC in the previous 2 years, and are attending the 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 urological investigations as part of normal clinical practice
  • Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
  • Patients who are able to give voluntary, written informed consent to participate in this study

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 or radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
  • Patients who have previously been diagnosed with renal cancer, prostate cancer, Muscle Invasive Bladder cancer, an upper tract tumour, or CiS in the prostatic urethra
  • Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test
  • Male patients undergoing active treatment for prostatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-muscle invasive bladder cancer patients in follow-up
Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.
Diagnostic test: ADXBLADDER
ADXBLADDER is a non-invasive, qualitative ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the monitoring of bladder cancer recurrence in non-muscle-invasive bladder cancer patients. Participants will be asked to provide a full void urine specimen, which will be centrifuged before the urine sediment is lysed. The lysed sample will then be tested with ADXBLADDER.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity and negative predictive value (NPV) of ADXBLADDDER will be calculated to establish the diagnostic accuracy for the detection of bladder cancer recurrence.
Time Frame: Urine samples will be collected from participants immediately prior to cystoscopy and analysed for MCM5 within 6 months. Overall performance characteristics of ADXBLADDER will be established following study completion.
The ADXBLADDER MCM5 results will be compared with the definitive diagnosis obtained by gold standard cystoscopy and pathological assessment of suspicious lesion(s) (where clinically indicated).
Urine samples will be collected from participants immediately prior to cystoscopy and analysed for MCM5 within 6 months. Overall performance characteristics of ADXBLADDER will be established following study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arquer Diagnostics Ltd

Investigators

  • Principal Investigator: Professor Ashish Kamat, The University of Texas MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arquer-US1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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