Investigation of three biomarkers for the detection of prostate cancer
Research type
Research Study
Full title
EVALUATION OF THE PERFORMANCE OF THE GLYCOSCORE BIOMARKERS FOR THE DETECTION OF CLINICALLY SIGNIFICANT PROSTATE CANCER
IRAS ID
340286
Contact name
Henry Lazarowicz
Contact email
Sponsor organisation
Medtechtomarket Consulting Ltd
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Prostate cancer is the most common cancer in men in the UK. It develops slowly and can remain undetected for many years. Unfortunately, the PSA test and mpMRI are not always that accurate in the diagnosis of prostate cancer which can lead onto unnecessary biopsies. There is an urgent clinical need to develop more accurate diagnostic tests that can be used as early as possible to help distinguish between clinically significant prostate cancer needing further treatment and cancer that may never cause problems. The purpose of this study is to evaluate the effectiveness of three biomarkers in human plasma for their ability to identify clinically significant prostate cancer, either alone, as a combination of the biomarkers or in combination with the PSA measurement
Medtechtomarket Limited is sponsoring a study on behalf of a diagnostics company GlycoScoreDX at The Royal Liverpool University Hospital.
Patients attending the hospital for a prostate biopsy who are either being investigated for suspected prostate cancer or are undergoing active surveillance for previously diagnosed prostate cancer will be asked to consent to a small sample of blood being taken before the biopsy and for study investigators to have access to their final diagnosis. The blood sample will be sent to Medtechtomarket Laboratories for measurement of the biomarkers and PSA. Patients will also be asked to consent to an additional tube of blood (from the same blood draw) and the urine sample which is routinely taken before the biopsy to be sent to the Liverpool University Biobank for future use in research studies.
All samples will be labelled with a study identification number only, no personally identifiable data will leave the collecting site.
137 male patients aged 18 years and above will be recruited for the study which is expected to take 12 months.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0150
Date of REC Opinion
30 Jul 2024
REC opinion
Further Information Favourable Opinion