Investigation of Urinary Biomarkers for the Detection of Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Urinary Biomarkers for the Detection of Breast Cancer

Conditions
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Liquid Biopsy, Breast Cancer, Urine

Intervention / Treatment
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* Device: Colli-Pee UAS devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sample collection<br>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<br>* Colli-Pee UAS device variants will be evaluated during this study<br>|

What is the study measuring?
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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. | 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 |
| --- | --- | --- |
| 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) | Through study completion, an average of 1 year | 
| 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. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker