Evaluation of the MCM5 ELISA in bladder cancer recurrence
Research type
Research Study
Full title
A PERFORMANCE EVALUATION STUDY OF ARQUER’S MCM5 ELISA TEST TO AID IN THE MONITORING OF BLADDER CANCER RECURRENCE
IRAS ID
224141
Contact name
Tim Dudderidge
Contact email
Sponsor organisation
Arquer Diagnostics Ltd
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
The objective of this study is to evaluate the performance Arquer's in vitro diagnostic test kit 'MCM5 ELISA' as an aid in detecting bladder cancer recurrence using urine specimens. Research has shown that detection of MCM5 in urine sediment is a sensitive and specific diagnostic test for bladder cancer. The study will be a multicentre, regulatory, prospective performance evaluation study of an in vitro diagnostic test. A total of 320 patients attending a hospital
urology clinic for bladder cancer recurrence monitoring will be asked to allow the use of a portion of a routinely collected urine sample to be analysed with the new ELISA test. Results of standard clinical investigations including cystoscopy and imaging will be recorded for each subject, with the ultimate diagnosis based on biopsy result if available. The results obtained with the MCM5
ELISA will be compared with the diagnosis based on standard clinical investigations in order to establish its utility in helping to diagnose bladder cancer recurrence. The results of the MCM5 ELISA test will in no way influence the treatment of the patient.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0174
Date of REC Opinion
8 Jun 2017
REC opinion
Favourable Opinion