Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554587
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Investigation of Three Biomarkers for the Detection of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 biomarkerbiomarkers 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
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
Detailed Description:
Worldwide prostate cancer is the most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men This amounted to 1414249 newly diagnosed cases and 375000 deaths worldwide yearly from this disease in 2020 Globally prostate cancer is the most commonly diagnosed cancer in more than fifty percent of countries 112 of 185 It presents a significant clinical burden in terms of volume and as a diagnostic challenge
The initial diagnosis of prostate cancer relies on the detection of PSA prostate specific antigen in patient blood While PSA is relatively good at identifying prostate cancer PSA levels can be elevated for reasons other than cancer giving a false positive result Two thirds of men with a raised PSA level dont have prostate cancer meaning that many men undergo unnecessary invasive follow up procedures such as tissue biopsy Prostate biopsies place a huge burden on both healthcare systems and individuals with suspected prostate cancer They are painful can lead to complications infections and in extreme circumstances death
Therefore the poor specificity of the PSA test combined with the disparate natural histories of many prostate cancers has limited its utility as a screening tool
A combination of clinical and pathological features such as the tumour grade Gleason score or Gleason Grade Group combined with clinical examination digital rectal examination MRI magnetic resonance imaging and isotope bone scan are commonly used to determine the aggressiveness and curability of tumours with radical treatment PSA measurement is used as part of this assessment but as other factors can influence PSA levels it cannot be used to assess risk or guide treatment in isolation
There remains an unmet clinical need for a better screening and diagnostic test for prostate cancer Such a test must also be able to differentiate between early low-risk cancers that do not require radical treatment and more aggressive tumours where radical treatment is preferable By identifying which patients have a clinically significant risk of prostate cancer we believe our test could provide a solution to both
The GlycoScore immunoassays detect the three biomarkers - glycosyltransferase enzymes in patient blood GALNT7 ST6GAL1 and GCNT1 which are linked to key tumour-associated glycans types of sugars on cell walls using an ELISA enzyme-linked immunosorbent assay-based platform
Initial studies conducted by Newcastle University using RUO research use only ELISA kits showed a significant correlation between prostate cancer and the three biomarkers ST6GAL1 GCNT1 and GALNT7 Extensive research and development work has been carried out developing custom antibody pairs and antigens for inclusion in our ELISA kit as well as to optimize buffers and other components
The purpose of this study is to obtain fresh patient blood samples to further evaluate the three biomarkers ST6GAL1 GCNT1 and GALNT7 for their ability to identify clinically significant prostate cancer either alone as a combination of the biomarkers or in combination with the PSA measurement obtained at Medtechtomarket using our in-house developed ELISA assays and a CE-marked PSA ELISA test kit
Diagnostic accuracy for participants with prostate cancer will be determined by comparison with biopsy results and for participants without prostate cancer comparison with mpMRI multi-parametric magnetic resonance imaging and biopsy results
Assessment of the correlation between the GlycoScore biomarker results with the full range of biopsy Gleason scoresGleason Grade groupCPG grade Cambridge Prognostic Group will allow an assessment of the prognostic value of the GlycoScore test and its potential use in the clinical management of prostate cancer
Patients attending the hospital for a transperineal 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 take part in the study Patients will be asked to consent to have a small sample of blood 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 to be taken 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
137 male patients aged 18 years and above will be recruited for the study which is expected to take 12 months
The initial diagnosis of prostate cancer relies on the detection of PSA prostate specific antigen in patient blood While PSA is relatively good at identifying prostate cancer PSA levels can be elevated for reasons other than cancer giving a false positive result Two thirds of men with a raised PSA level dont have prostate cancer meaning that many men undergo unnecessary invasive follow up procedures such as tissue biopsy Prostate biopsies place a huge burden on both healthcare systems and individuals with suspected prostate cancer They are painful can lead to complications infections and in extreme circumstances death
Therefore the poor specificity of the PSA test combined with the disparate natural histories of many prostate cancers has limited its utility as a screening tool
A combination of clinical and pathological features such as the tumour grade Gleason score or Gleason Grade Group combined with clinical examination digital rectal examination MRI magnetic resonance imaging and isotope bone scan are commonly used to determine the aggressiveness and curability of tumours with radical treatment PSA measurement is used as part of this assessment but as other factors can influence PSA levels it cannot be used to assess risk or guide treatment in isolation
There remains an unmet clinical need for a better screening and diagnostic test for prostate cancer Such a test must also be able to differentiate between early low-risk cancers that do not require radical treatment and more aggressive tumours where radical treatment is preferable By identifying which patients have a clinically significant risk of prostate cancer we believe our test could provide a solution to both
The GlycoScore immunoassays detect the three biomarkers - glycosyltransferase enzymes in patient blood GALNT7 ST6GAL1 and GCNT1 which are linked to key tumour-associated glycans types of sugars on cell walls using an ELISA enzyme-linked immunosorbent assay-based platform
Initial studies conducted by Newcastle University using RUO research use only ELISA kits showed a significant correlation between prostate cancer and the three biomarkers ST6GAL1 GCNT1 and GALNT7 Extensive research and development work has been carried out developing custom antibody pairs and antigens for inclusion in our ELISA kit as well as to optimize buffers and other components
The purpose of this study is to obtain fresh patient blood samples to further evaluate the three biomarkers ST6GAL1 GCNT1 and GALNT7 for their ability to identify clinically significant prostate cancer either alone as a combination of the biomarkers or in combination with the PSA measurement obtained at Medtechtomarket using our in-house developed ELISA assays and a CE-marked PSA ELISA test kit
Diagnostic accuracy for participants with prostate cancer will be determined by comparison with biopsy results and for participants without prostate cancer comparison with mpMRI multi-parametric magnetic resonance imaging and biopsy results
Assessment of the correlation between the GlycoScore biomarker results with the full range of biopsy Gleason scoresGleason Grade groupCPG grade Cambridge Prognostic Group will allow an assessment of the prognostic value of the GlycoScore test and its potential use in the clinical management of prostate cancer
Patients attending the hospital for a transperineal 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 take part in the study Patients will be asked to consent to have a small sample of blood 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 to be taken 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
137 male patients aged 18 years and above will be recruited for the study which is expected to take 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None