Breast CancerURODETECT-WP3NCT05453591
Investigation of Urinary Biomarkers for the Detection of Breast Cancer
A study testing Colli-Pee UAS devices in people with Breast Cancer and Urine, run by Novosanis NV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Urine, Liquid Biopsy
- What is being tested?
- Colli-Pee UAS devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Dec 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being at least 18 years old
- Being able to understand and read Dutch
- For cancer patients: diagnosed with breast cancer
Who cannot join
- For cancer patients: suffering from a blood cancer
- For healthy volunteers: diagnosed with cancer
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair ziekenhuis Antwerpen
Edegem, Antwerpen, 2650
Wiebren Tjalma, Prof. Dr., +32 3 821 32 50, borstkliniek@uza.be
About this study
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
- Being tested
- Colli-Pee UAS devices
- Keywords
- First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colli-Pee UAS devicesDevice
Colli-Pee UAS device variants will be evaluated during this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Colli-Pee UAS devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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)
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start21 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novosanis NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453591
- Sponsor's protocol ID
- RECO_CT29B
- Acronym
- URODETECT-WP3
- Status last verified
- Mar 2023
- First submitted
- 24 Jun 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Urinary Biomarkers for the Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT05453591
- Acronym / sponsor ID
- URODETECT-WP3 / RECO_CT29B
- Conditions
- Breast Cancer, Urine, Liquid Biopsy
- Keywords
- First-void urine, Liquid biopsy, Oncology, Colli-Pee, Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Novosanis NVIndustry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection | Experimental | Device: Colli-Pee UAS devicesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being at least 18 years old
- Being able to understand and read Dutch
- For cancer patients: diagnosed with breast cancer
Key exclusion criteria (2 listed)
- For cancer patients: suffering from a blood cancer
- For healthy volunteers: diagnosed with cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colli-Pee UAS devicesColli-Pee UAS device variants will be evaluated during this study | Device | Sample collection |
Primary outcome
Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
Time frame: Through study completion, an average of 1 year.
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)
2 secondary outcomes
Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
Time frame: Through study completion, an average of 1 year
Usability characteristics of the Colli-Pee UAS devices.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colli-Pee UAS devices in people with Breast Cancer and Urine, run by Novosanis NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Jordaens, PhD student (+32497610800, stephanie.jordaens@novosanis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.