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

Breast Cancer Clinical Trial

— URODETECT-WP1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05453604
• Other study ID #: 2019_NOV_CP_001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Novosanis NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Liquid Biopsy
• Neoplasms
• Prostate Cancer
• Urine

Intervention

Device:
• Colli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study

Locations

Country	Name	City	State
Belgium	Universitair ziekenhuis Antwerpen	Edegem	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
Novosanis NV	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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	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
Secondary	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