Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT05508568
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Sponsor:
Arquer Diagnostics Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: