Investigation of Urinary Biomarkers for the Detection of Breast Cancer (URODETECT-WP3)

March 22, 2023 updated by: Novosanis NV

The aim of this study is to investigate and possibly validate urinary biomarkers for breast 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 breast 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being at least 18 years old
  • Being able to understand and read Dutch
  • For cancer patients: diagnosed with breast cancer

Exclusion Criteria:

  • For cancer patients: suffering from a blood cancer
  • For healthy volunteers: diagnosed with cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 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.
Device: Colli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast 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 breast cancer patients compared to age- and sex-matched healthy volunteers. (Proof of concept study)
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability characteristics of the Colli-Pee UAS devices.
Time Frame: 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.
Through study completion, an average of 1 year
Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast 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 all study participants compared to blood testing using ddPCR. (Proof of concept study)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosanis NV

Collaborators

Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECO_CT29B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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