Investigation of Three Biomarkers for the Detection of Prostate Cancer
Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer
Medtechtomarket Consulting Ltd
137 participants
Jan 7, 2025
OBSERVATIONAL
Conditions
Summary
GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test. This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.
Eligibility
Inclusion Criteria3
- Male patients aged 18 years and over
- The patient is being investigated for suspected prostate cancer or is on active surveillance
- The patient is able to give consent to take part in the study
Exclusion Criteria4
- A patient who has already taken part in the study
- A patient with an active urinary tract infection
- The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)
- The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product
Interventions
Measurement of the plasma concentration of ST6GAL1, GCNT1 and GALNT7 biomarkers in patients suspected of having prostate cancer or on active surveillance
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06554587