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

Description

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.

Conditions

Bladder Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Denver

The Urology Center of Colorado, Denver, Colorado, United States, 80211

Daytona Beach

Advanced Urology Institute, Daytona Beach, Florida, United States, 32114

Jeffersonville

First Urology, Jeffersonville, Indiana, United States, 47130

Troy

Michigan Institute of Urology, Troy, Michigan, United States, 48084

Mount Laurel

New Jersey Urology, Mount Laurel, New Jersey, United States, 08054

Syracuse

Associated Medical Professionals of NY, Syracuse, New York, United States, 13210

Cleveland

Clinical Research Solutions, Cleveland, Ohio, United States, 44130

Philadelphia

MidLantic Urology, Philadelphia, Pennsylvania, United States, 19004

Myrtle Beach

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States, 29572

San Antonio

Urology San Antonio, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arquer Diagnostics Ltd,

Professor Ashish Kamat, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center

Study Record Dates

2023-04