NCT05453604

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novosanis NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Prostate Cancer
• Urine
• Liquid Biopsy

Interventions

Type	Name	Description
DEVICE	Colli-Pee UAS devices	Colli-Pee UAS device variants will be evaluated during this study

Timeline

• Start date: 2020-06-18
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2022-07-12
• Last updated: 2023-11-13

Locations

1 site across 1 country: Belgium