Investigation of Urinary Biomarkers for the Detection of Prostate Cancer

NCT ID: NCT05454371

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2023-12-31

Brief Summary

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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 ColliPeeĀ® 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

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Conditions

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Prostate Cancer Urine Liquid Biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sample collection

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 ColliPeeĀ® device and fill out an online questionnaire to collect usability data.

Group Type EXPERIMENTAL

Colli-Pee UAS devices

Intervention Type DEVICE

Colli-Pee UAS device variants will be evaluated during this study

Interventions

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Colli-Pee UAS devices

Colli-Pee UAS device variants will be evaluated during this study

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Novosanis NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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RECO_CT29A

Identifier Type: -

Identifier Source: org_study_id

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