Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer

Recruiting

Conditions: Prostate Cancer
10038597
10036958

Registration Number: NL-OMON49657

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 225

Inclusion Criteria

Patients with a PSA concentration >3 ng/mL that visit the urologist for further
examination.

Exclusion Criteria

Patients with a PSA concentration <3 ng/mL, patients that have a cystitis
(bladder infection), are in the process of undergoing chemo therapy or using
5-alpha reductase inhibitors will be excluded from the study. Patients with a
history or presence of cancers, or non-prostate urological disorders.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following parameters/outcomes are expected:<br /><br><br /><br>Regarding patient information:<br /><br><br /><br>• Study number<br /><br>• ID-code<br /><br>• Birth date<br /><br>• Ethnicity<br /><br>• Date of sample collection<br /><br>• Volume of prostate (echo)<br /><br>• PSA-concentration<br /><br>• Gleason score<br /><br>• Number of biopsies taken<br /><br>• Number of positive biopsies<br /><br>• cT-stage<br /><br>• Positive lymph nodes<br /><br>• Metastasis in the bone<br /><br>• Other diseases<br /><br>• Medication<br /><br>• BRCA mutation<br /><br>• Treatment<br /><br>• Prostate MRI<br /><br>• Cribriform growth<br /><br>• Family anamneses<br /><br><br /><br>The research will provide the following outcomes:<br /><br>• Relative ratio of different glycoforms in urine and plasma<br /><br>• Normalization of glycoforms per glycosylation trait (derived trait)<br /><br>• The difference (delta) between urine and plasma for the found derived traits</p><br>

Secondary Outcome Measures