An interventional study of Colli-Pee UAS devices in Prostate Cancer, Urine and Liquid Biopsy, sponsored by Novosanis NV. Withdrawn at 1 site in Belgium. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Novosanis NV · Not applicable, Interventional, and Diagnostic
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.
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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 breast- or 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.
Device: Colli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study
Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
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)
Time frame: Through study completion, an average of 1 year.
Detection (absence/presence) of specific biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
Comparison of target detection measured using ddPCR assays \[positive, negative or copies/µL\] in first-void urine samples from all study participants compared to blood testing using ddPCR. (Proof of concept study)
Time frame: Through study completion, an average of 1 year
Usability characteristics of the Colli-Pee UAS devices.
All study participants will receive a questionnaire regarding the usability characteristic of the Colli-Pee UAS devices. These questions cover physical information, previous experiences, and usability questions. When scores need to be given participants can score between 0 and 100%, in which 0% is a negative score and 100% is a positive score. When an opinion is asked participants can choose between very difficult, difficult, neutral, easy, and very easy. Analysis will be done using descriptive statistics.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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