Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications

Study Overview
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Brief Summary
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The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods. This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.

Official Title
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Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications

Conditions
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Urine, Breast Cancer, Prostate Cancer, Liquid Biopsy

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 specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer) Exclusion Criteria: For cancer patients specifically: patients suffering from a blood 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, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. | 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 |
| --- | --- | --- |
| General DNA or RNA concentration measured using Qubit | Comparison of DNA or RNA concentrations [ng/µL] measured using Qubit assays between different extraction methods; between different first-void urine volumes (10, 20, 40 mL); between different storage conditions (Day 0, Day 7, Day 14 at room temperature). | Through study completion, an average of 1 year. | 
| Protein concentration measured using ELISA | Comparison of protein concentrations measured using ELISA assays between different extraction methods; between different first-void urine volumes (10, 20, 40 mL); between different storage conditions (Day 0, Day 7, Day 14 at room temperature). | Through study completion, an average of 1 year. | 
| cell-free DNA or RNA percentages and profiles measured using TapeStation | Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays between different extraction methods; between different first-void urine volumes (10, 20, 40 mL); between different storage conditions (Day 0, Day 7, Day 14 at room temperature). | Through study completion, an average of 1 year | 
| Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR | Comparison of target detection measured using ddPCR assays [copies/µL] between different extraction methods; between different first-void urine volumes (10, 20, 40 mL]; between different storage conditions (Day 0, Day 7, Day 14 at room temperature). | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate 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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Urine, Colli-Pee, Liquid biopsy, Oncology