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

Arquer Diagnostics

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Diagnostic Test: ADXBLADDER

Study type: Observational

Funder types: Industry

Identifiers

NCT05508568

Arquer-US1

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

650 participants in 1 patient group

Non-muscle invasive bladder cancer patients in follow-up

Description:

Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.

Treatment:

Diagnostic Test: ADXBLADDER