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

Novosanis

Status: Active, not recruiting

Conditions: Breast Cancer; Urine; Liquid Biopsy; Prostate Cancer

Treatments: Device: Colli-Pee UAS devices

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05453604

2019_NOV_CP_001

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Sample collection

Experimental group

Description:

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.

Treatment:

Device: Colli-Pee UAS devices