Back to resultsPSA Glycomics Assay for Early Detection of Prostate Cancer
Primary Purpose
Prostate Cancer, PSA
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PSA Glycomics Assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, PSA, Glycomics Assay
Eligibility Criteria
Inclusion Criteria:
- Patients with elevated PSA (>3 ng/mL)
- Signed informed consent
Exclusion Criteria:
- Patients that have a cystitis (bladder infection)
- Patients under chemotherapy
- Patients using 5-alpha reductase inhibitors
- History or presence of cancers, or non-prostate urological disorders.
Sites / Locations
- Amsterdam UMC, location AMC
- Amsterdam UMC, location VUmcRecruiting
- Leiden University Medical CentreRecruiting
Outcomes
Primary Outcome Measures
PSA Glycomics Assay
The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT04393376
First Posted
May 14, 2020
Last Updated
September 22, 2023
Sponsor
Prof.dr. H.P. Beerlage
Collaborators
Amsterdam UMC, location VUmc, The Netherlands Cancer Institute, Radboud University Medical Center, Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04393376
Brief Title
PSA Glycomics Assay for Early Detection of Prostate Cancer
Official Title
Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof.dr. H.P. Beerlage
Collaborators
Amsterdam UMC, location VUmc, The Netherlands Cancer Institute, Radboud University Medical Center, Leiden University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, PSA
Keywords
Prostate Cancer, PSA, Glycomics Assay
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
PSA Glycomics Assay
Intervention Description
PSA Glycomics Assay will be performed on urine and blood samples
Primary Outcome Measure Information:
Title
PSA Glycomics Assay
Description
The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with elevated PSA (>3 ng/mL)
Signed informed consent
Exclusion Criteria:
Patients that have a cystitis (bladder infection)
Patients under chemotherapy
Patients using 5-alpha reductase inhibitors
History or presence of cancers, or non-prostate urological disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J R Oddens, MD, PhD
Phone
+31(0)20-5668637
Email
j.r.oddens@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Completed
Facility Name
Amsterdam UMC, location VUmc
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.R. Oddens, MD, PhD
Email
j.r.oddens@amsterdamumc.nl
Facility Name
Leiden University Medical Centre
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guinevere Kammeijer, MD, PhD
Email
g.s.m.kammeijer@lumc.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
PSA Glycomics Assay for Early Detection of Prostate Cancer
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