Investigation of Urinary Biomarkers for the Detection of Breast Cancer

NCT05453591 | Unknown

• 1 other identifier: RECO_CT29B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Urine; Liquid Biopsy

Keywords

First-void urine; Liquid biopsy; Oncology; Colli-Pee; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.

  Through study completion, an average of 1 year

• Usability characteristics of the Colli-Pee UAS devices.

  Through study completion, an average of 1 year

Study Arms (1)

Sample collection

EXPERIMENTAL

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.

Device: Colli-Pee UAS devices

Interventions

Colli-Pee UAS devices DEVICE

Colli-Pee UAS device variants will be evaluated during this study

Sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old
• Being able to understand and read Dutch
• For cancer patients: diagnosed with breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• Novosanis NV: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Stephanie Jordaens, PhD student

CONTACT

+32497610800; stephanie.jordaens@novosanis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 12, 2022
• Study Start: December 21, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)