Investigation of Urinary Biomarkers for the Detection of Breast Cancer

Breast Cancer Clinical Trial

— URODETECT-WP3  

Official title:

Investigation of Urinary Biomarkers for the Detection of Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453591
• Other study ID #: RECO_CT29B
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Novosanis NV
• Contact: Stephanie Jordaens, PhD student
• Phone: +32497610800
• Email: stephanie.jordaens[@]novosanis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: December 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: diagnosed with breast cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liquid Biopsy
• 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	Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.	Comparison of target detection measured using ddPCR assays [positive, negative or copies/µL] in first-void urine samples from breast cancer patients compared to age- and sex-matched healthy volunteers. (Proof of concept study)	Through study completion, an average of 1 year.
Secondary	Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast 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