Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Bladder Cancer

Estimated Enrollment:

650

Study ID:

NCT05508568

Recruitment Status:

Recruiting

Sponsor:

Arquer Diagnostics Ltd

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There are 13 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

650

Study ID:

NCT05508568

Recruitment Status:

Recruiting

Sponsor:


Arquer Diagnostics Ltd

How clear is this clinincal trial information?

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