Cervical CancerCASUS-WP1NCT04480866
CASUS: Improved and Quality Assured Collection of First-void Urine
A study testing Colli-Pee® (FV5000 and Small Volumes) in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus
- What is being tested?
- Colli-Pee® (FV5000 and Small Volumes)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jul 2019to 27 Nov 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18 years and older
- Women with a high-risk HPV positive test result within six months prior to study enrolment.
- Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
- Able to understand the information brochure/what the study is about.
Who cannot join
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
- Participating in another interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp
Wilrijk, Antwerpen, 2610
About this study
Official title: Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).
Read the detailed description
CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void urine, a next-generation first-void urine collection device is necessary, which includes internal process control, novel collector tubes for collection of smaller urine volumes, and integration of a non-toxic nucleic acid preservative.
Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard' Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The optimal urine volume needed for detection of host and viral biomarkers, as well as optimization of the nucleic acid preservative solution by introduction of a sample/extraction validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using different DNA extraction protocols.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma, Urine
- Being tested
- Colli-Pee® (FV5000 and Small Volumes)
- Keywords
- Biomarker, First-void urine, Screening, Triage
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colli-Pee® (FV5000 and Small Volumes)Device
Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL.
Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.
| Study group | Role | What they receive |
|---|---|---|
| First-void urine collection | Other | Women self-collect three first-void urine samples (random order) at home. Receives: Device: Colli-Pee® (FV5000 and Small Volumes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human DNA (GAPDH)
Comparison of human DNA (GAPDH) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Measured: Evaluation/testing when all samples are collected [1 year]
Internal control DNA (IC DNA)
Comparison of internal control DNA (IC DNA) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Measured: Evaluation/testing when all samples are collected [1 year]
Human DNA reference gene (ACTB)
Comparison of human DNA reference gene (ACTB) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
Measured: Evaluation/testing when all samples are collected [1 year]
Secondary outcomes (2)
Human DNA (Beta-globin)
Comparison of human DNA (Beta-globin) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
Measured: Evaluation/testing when all samples are collected [1 year]
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
Comparison of HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) positivity (+/-) and concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
Measured: Evaluation/testing when all samples are collected [1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start30 Jul 2019
- Primary completion25 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Novosanis NV, Self-screen B.V.
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Pierre Van Damme, MD, PhD, Principal investigator, Universiteit AntwerpenAlex Vorsters, Ir, PhD, Study chair, Universiteit AntwerpenSeverien Van Keer, PhD, Study chair, Universiteit AntwerpenLaura Téblick, Ir, Study chair, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480866
- Sponsor's protocol ID
- B300201940120
- Acronym
- CASUS-WP1
- Status last verified
- Jul 2020
- First submitted
- 2 Jun 2020
- Last updated
- 21 Jul 2020
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
- ClinicalTrials.gov ID
- NCT04480866
- Acronym / sponsor ID
- CASUS-WP1 / B300201940120
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma, Urine
- Keywords
- Biomarker, First-void urine, Screening, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Novosanis NV, Self-screen B.V.
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 21 Jul 2020 (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 goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).
Detailed description
CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void urine, a next-generation first-void urine collection device is necessary, which includes internal process control, novel collector tubes for collection of smaller urine volumes, and integration of a non-toxic nucleic acid preservative.
Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard' Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The optimal urine volume needed for detection of host and viral biomarkers, as well as optimization of the nucleic acid preservative solution by introduction of a sample/extraction validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using different DNA extraction protocols.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-void urine collection | Other | Device: Colli-Pee® (FV5000 and Small Volumes)Women self-collect three first-void urine samples (random order) at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- 18 years and older
- Women with a high-risk HPV positive test result within six months prior to study enrolment.
- Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
- Able to understand the information brochure/what the study is about.
Key exclusion criteria (2 listed)
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
- Participating in another interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
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® (FV5000 and Small Volumes)Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL. Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order. | Device | First-void urine collection |
Primary outcome
Human DNA (GAPDH)
Time frame: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA (GAPDH) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Internal control DNA (IC DNA)
Time frame: Evaluation/testing when all samples are collected [1 year]
Comparison of internal control DNA (IC DNA) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Human DNA reference gene (ACTB)
Time frame: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA reference gene (ACTB) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
2 secondary outcomes
Human DNA (Beta-globin)
Time frame: Evaluation/testing when all samples are collected [1 year]
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
Time frame: Evaluation/testing when all samples are collected [1 year]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
Pierre Van Damme, MD, PhD principal investigator
Universiteit Antwerpen
Alex Vorsters, Ir, PhD study chair
Universiteit Antwerpen
Severien Van Keer, PhD study chair
Universiteit Antwerpen
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® (FV5000 and Small Volumes) in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Universiteit Antwerpen 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 5 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: finished, as of the sponsor's last update on 21 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Human DNA (GAPDH) (time frame: Evaluation/testing when all samples are collected [1 year]). The study lists 3 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 21 Jul 2020.