Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Novosanis NV
- Locations
- 1
- Primary Endpoint
- Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this study is to investigate and possibly validate urinary biomarkers for prostate cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.
This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with prostate cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Being at least 18 years old
- •Being able to understand and read Dutch
- •For cancer patients: being diagnosed with prostate cancer
- •For healthy volunteers: being male
Exclusion Criteria
- •For cancer patients: suffering from a blood cancer
- •For healthy volunteers: diagnosed with cancer
Outcomes
Primary Outcomes
Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
Time Frame: Through study completion, an average of 1 year.
Comparison of target detection measured using ddPCR assays \[positive, negative or copies/µL\] in first-void urine samples from prostate cancer patients compared to age- and sex-matched healthy volunteers. (Proof of concept study)
Secondary Outcomes
- Detection (absence/presence) of specific biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.(Through study completion, an average of 1 year)
- Usability characteristics of the Colli-Pee UAS devices.(Through study completion, an average of 1 year)