Breast CancerURODETECT-WP1NCT05453604
Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
A study testing Colli-Pee UAS devices in people with Breast Cancer and Prostate Cancer, run by Novosanis NV at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized… 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, Prostate Cancer, Urine
- 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
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jun 2020to Dec 2023
- 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 specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer)
Who cannot join
- For cancer patients specifically: patients suffering from a blood cancer
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods.
This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.
- Conditions
- Breast Cancer, Prostate Cancer, Urine, Liquid Biopsy
- Being tested
- Colli-Pee UAS devices
- Keywords
- Urine, Liquid biopsy, Oncology, Colli-Pee
- Medical subject headings
- Breast Neoplasms, Prostatic 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, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Receives: Device: Colli-Pee UAS devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
General DNA or RNA concentration measured using Qubit
Comparison of DNA or RNA concentrations [ng/µL] measured using Qubit assays
- between different extraction methods;
- between different first-void urine volumes (10, 20, 40 mL);
- between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Measured: Through study completion, an average of 1 year.
Protein concentration measured using ELISA
Comparison of protein concentrations measured using ELISA assays
- between different extraction methods;
- between different first-void urine volumes (10, 20, 40 mL);
- between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Measured: Through study completion, an average of 1 year.
cell-free DNA or RNA percentages and profiles measured using TapeStation
Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays
- between different extraction methods;
- between different first-void urine volumes (10, 20, 40 mL);
- between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Measured: Through study completion, an average of 1 year
Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR
Comparison of target detection measured using ddPCR assays [copies/µL]
- between different extraction methods;
- between different first-void urine volumes (10, 20, 40 mL];
- between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate 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 start18 Jun 2020
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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
- 105 participants (actual)
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
- NCT05453604
- Sponsor's protocol ID
- 2019_NOV_CP_001
- Acronym
- URODETECT-WP1
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2022
- Last updated
- 13 Nov 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
- ClinicalTrials.gov ID
- NCT05453604
- Acronym / sponsor ID
- URODETECT-WP1 / 2019_NOV_CP_001
- Conditions
- Breast Cancer, Prostate Cancer, Urine, Liquid Biopsy
- Keywords
- Urine, Liquid biopsy, Oncology, Colli-Pee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Novosanis NVIndustry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (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 evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods.
This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.
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, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. |
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 specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer)
Key exclusion criteria (1 listed)
- For cancer patients specifically: patients suffering from a blood 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
General DNA or RNA concentration measured using Qubit
Time frame: Through study completion, an average of 1 year.
Comparison of DNA or RNA concentrations [ng/µL] measured using Qubit assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Protein concentration measured using ELISA
Time frame: Through study completion, an average of 1 year.
Comparison of protein concentrations measured using ELISA assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
cell-free DNA or RNA percentages and profiles measured using TapeStation
Time frame: Through study completion, an average of 1 year
Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL); * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR
Time frame: Through study completion, an average of 1 year
Comparison of target detection measured using ddPCR assays [copies/µL] * between different extraction methods; * between different first-void urine volumes (10, 20, 40 mL]; * between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
2 secondary outcomes
Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate 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 13 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostate Cancer, 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 1 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 13 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General DNA or RNA concentration measured using Qubit (time frame: Through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. 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 13 Nov 2023.