NCT05508568

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Arquer Diagnostics Ltd · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2022-08-19
• Last updated: 2023-02-01

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study