Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Royal Liverpool University Hospital
RECRUITING
Liverpool
Contact Information
Primary
Rebecca Newman, BSc
rebecca.newman@medtechtomarket.com
07595 298 248
Backup
Lindsay Traynor, BSc
lindsay.traynor@medtechtomarket.com
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2026-03-07
Participants
Target number of participants: 137
Treatments
Patients with suspected prostate cancer or on active surveillance
Diagnostic tests to measure three separate biomarkers in blood taken from patients pre-biopsy to assess the diagnostic performance of the biomarkers in detecting clinically significant prostate cancer (Gleason score ≥7)
Related Therapeutic Areas
Sponsors
Leads: Medtechtomarket Consulting Ltd
Collaborators: GlycoscoreDx Ltd

This content was sourced from clinicaltrials.gov