Investigation of Urinary Biomarkers for the Detection of Prostate Cancer

Not Applicable

Withdrawn

• Conditions: Liquid Biopsy; Prostate Cancer; Urine
• Interventions: Device: Colli-Pee UAS devices

• Registration Number: NCT05454371
• Lead Sponsor: Novosanis NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Study Start: 2023-12
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sample collection	Colli-Pee UAS devices	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.

Primary Outcome Measures

Name	Time	Method
Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.	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 Outcome Measures

Name	Time	Method
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	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)
Usability characteristics of the Colli-Pee UAS devices.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Universitair ziekenhuis Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium