Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications (URODETECT-WP1)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Prostate Cancer; Urine; Liquid Biopsy
• Intervention / Treatment: Device: Colli-Pee UAS devices

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Jordaens, PhD student; Phone Number: +32497610800; Email: stephanie.jordaens@novosanis.com

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Universitair Ziekenhuis Antwerpen
      • Contact: Tjalma, Prof. Dr.; Phone Number: +32 3 821 32 50; Email: borstkliniek@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sample collection; 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; Colli-Pee UAS device variants will be evaluated during this study

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Novosanis NV
• Collaborators: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Urine; Oncology; Liquid biopsy; Colli-Pee
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2019_NOV_CP_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No