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

Primary Purpose

Breast Cancer, Urine, Liquid Biopsy

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Colli-Pee UAS devices
Sponsored by
Novosanis NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair ziekenhuis AntwerpenRecruiting

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 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.

Outcomes

Primary Outcome Measures

Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
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)

Secondary Outcome Measures

Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast 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

First Posted
June 24, 2022
Last Updated
March 22, 2023
Sponsor
Novosanis NV
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT05453591
Brief Title
Investigation of Urinary Biomarkers for the Detection of Breast Cancer
Acronym
URODETECT-WP3
Official Title
Investigation of Urinary Biomarkers for the Detection of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Urine, Liquid Biopsy
Keywords
First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker

7. Study Design

Primary Purpose
Other
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 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.
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 (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast 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 breast 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 (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast 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
All
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: diagnosed with breast cancer Exclusion Criteria: For cancer patients: suffering from a blood cancer For healthy volunteers: diagnosed with cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Jordaens, PhD student
Phone
+32497610800
Email
stephanie.jordaens@novosanis.com
Facility Information:
Facility Name
Universitair ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiebren Tjalma, Prof. Dr.
Phone
+32 3 821 32 50
Email
borstkliniek@uza.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of Urinary Biomarkers for the Detection of Breast Cancer

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