Breast Cancer, Liquid Biopsy, Urine
Conditions
Keywords
First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker
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.
Interventions
DEVICEColli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study
Sponsors
Universiteit Antwerpen
Novosanis NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR. | 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) |
| Usability characteristics of the Colli-Pee UAS devices. | 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. |
Countries
Belgium
Contacts
Primary ContactStephanie Jordaens, PhD student
Outcome results
None listed