Investigation of Urinary Biomarkers for the Detection of Breast Cancer

NCT ID: NCT05453591

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-21

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 ColliPeeĀ® 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Urine Liquid Biopsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sample collection

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 ColliPeeĀ® 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.

Group Type EXPERIMENTAL

Colli-Pee UAS devices

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colli-Pee UAS devices

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Novosanis NV

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephanie Jordaens, PhD student

Role: CONTACT

+32497610800

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wiebren Tjalma, Prof. Dr.

Role: primary

+32 3 821 32 50

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECO_CT29B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Detection of Breast Cancer
NCT06043661 RECRUITING
Personalized Breast Cancer Screening
NCT06060938 ACTIVE_NOT_RECRUITING NA