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

Status unconfirmed

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT05508568

Run by

Arquer Diagnostics Ltd

People needed

650

Starts

2021-07-01

Expected to finish

2023-04-01

Last updated by the study team

2023-02-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Urology Center of Colorado — Denver, Colorado, United States (enrolling)
• Advanced Urology Institute — Daytona Beach, Florida, United States (enrolling)
• First Urology — Jeffersonville, Indiana, United States (enrolling)
• Michigan Institute of Urology — Troy, Michigan, United States (enrolling)
• New Jersey Urology — Mount Laurel, New Jersey, United States (enrolling)
• Associated Medical Professionals of NY — Syracuse, New York, United States (enrolling)
• Clinical Research Solutions — Cleveland, Ohio, United States (enrolling)
• MidLantic Urology — Philadelphia, Pennsylvania, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Urology San Antonio — San Antonio, Texas, United States (enrolling)
• Virginia Urology Center — Richmond, Virginia, United States (enrolling)
• Urology of Virginia — Virginia Beach, Virginia, United States (enrolling)
• Spokane Urology — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.