Evaluation of the MCM5 ELISA in the diagnosis of Prostate Cancer
Research type
Research Study
Full title
A PERFORMANCE EVALUATION STUDY OF ARQUER’S MCM5 ELISA TEST TO AID IN THE DIAGNOSIS OF PROSTATE CANCER
IRAS ID
235420
Contact name
Stuart McCracken
Contact email
Sponsor organisation
Arquer Diagnostics
Duration of Study in the UK
0 years, 3 months, 27 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 prostate cancer using urine specimens collected following a digital rectal exam (DRE), and in semen samples. Research has shown that detection of MCM5 in urine sediment is a sensitive and specific diagnostic test for prostate cancer (Dudderidge et al 2010).
The study will be a multicentre, regulatory, prospective performance evaluation study of an in vitro diagnostic test. A total of 250 patients attending a hospital urology clinic for prostate biopsy will be asked to allow the use of a portion of a routinely collected urine sample (to be provided following DRE), and if possible that they provide a semen sample, both of which are to be analysed with the new ELISA test. Results of standard clinical investigations including prostate biopsy and MRI imaging will be recorded for each subject, with the ultimate diagnosis based on biopsy result. 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 prostate cancer.
The results of the MCM5 ELISA test will in no way influence the treatment of the patient.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0351
Date of REC Opinion
14 Dec 2017
REC opinion
Further Information Favourable Opinion