Investigation of Urinary Biomarkers for the Detection of Prostate Cancer (URODETECT-WP2)
Primary Purpose
Prostate Cancer, Urine, Liquid Biopsy
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Colli-Pee UAS devices
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring First-void urine, Liquid biopsy, Oncology, Biomarker, Colli-Pee
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
Sites / Locations
- Universitair ziekenhuis Antwerpen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sample collection
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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.
Full Information
NCT ID
NCT05454371
First Posted
June 24, 2022
Last Updated
March 22, 2023
Sponsor
Novosanis NV
Collaborators
Universiteit Antwerpen
1. Study Identification
Unique Protocol Identification Number
NCT05454371
Brief Title
Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
Acronym
URODETECT-WP2
Official Title
Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Study is part of PhD trajectory and currently the achievability is under question.
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novosanis NV
Collaborators
Universiteit Antwerpen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Urine, Liquid Biopsy
Keywords
First-void urine, Liquid biopsy, Oncology, Biomarker, Colli-Pee
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sample collection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Colli-Pee UAS devices
Intervention Description
Colli-Pee UAS device variants will be evaluated during this study
Primary Outcome Measure Information:
Title
Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
Description
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.
Secondary Outcome Measure Information:
Title
Detection (absence/presence) of specific biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
Description
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
Title
Usability characteristics of the Colli-Pee UAS devices.
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universitair ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
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