Investigation of Urinary Biomarkers for the Detection of Breast Cancer (URODETECT-WP3)

Novosanis

Status: Enrolling

Conditions: Breast Cancer; Urine; Liquid Biopsy

Treatments: Device: Colli-Pee UAS devices

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05453591

RECO_CT29B

Details and patient eligibility

About

The aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.

This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with breast cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.

Enrollment: 200 estimated 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: diagnosed with breast cancer

Exclusion criteria

• For cancer patients: suffering from a blood cancer
• For healthy volunteers: diagnosed with cancer

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 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 and urine samples and a blood sample from cancer patients with breast cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.

Treatment:

Device: Colli-Pee UAS devices