Evaluation of Arquer's MCM5 ELISA in the diagnosis of bladder cancer
Research type
Research Study
Full title
A PERFORMANCE EVALUATION STUDY OF ARQUER’S MCM5 ELISA TEST TO AID IN THE DIAGNOSIS OF BLADDER CANCER
IRAS ID
191587
Contact name
Sarah Couch
Contact email
Sponsor organisation
Arquer Diagnostics Ltd
Duration of Study in the UK
0 years, 6 months, 1 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 diagnosing bladder cancer 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 multi-centre, regulatory, prospective performance evaluation study of an in vitro diagnostic test. A total of 800 patients attending a hospital urology/haematuria clinic who present with haematuria or lower urinary tract symptoms suggestive of a risk of bladder cancer 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 flexible 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. The results of the Mcm5 ELISA test will in no way influence the treatment of the patient.
REC name
HSC REC B
REC reference
15/NI/0258
Date of REC Opinion
26 Nov 2015
REC opinion
Further Information Favourable Opinion