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Cervical CancerCASUS-WP4NCT04530201

CASUS: Validation for Detection of Precursor Lesions

A study testing Colli-Pee Small Volumes (10 mL) device in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Universiteit Antwerpen at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 25 to 64 years, women only
What is being tested?
Colli-Pee Small Volumes (10 mL) device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
3 sitesBelgium
Study dates
20 Aug 2020to 28 Feb 2022
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 25 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female
  • 25 years until 64 years old
  • Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
  • Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
  • Is able to understand the information brochure/what the study is about.

Who cannot join

  • Women that underwent hysterectomy
  • Pregnant women
  • Treatment for cervical cancer in the last 6 months before participation in the study
  • Participating in an 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

3 sites in 1 country.

Belgium3 sites

  • Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)

    Ghent, Oost-Vlaanderen, 9000

  • Gynécologie-obstétrique - CHU de Liège

    Liège, 4030

  • Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen

    Tienen, Vlaams-Brabant, 3300

Other trials in Belgium

About this study

Official title: Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions

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 4 (WP4):

The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device, Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. The number of women in this cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA extracts of first-void samples after optimization of sample volume, internal process control, and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp, Belgium).

Being tested
Colli-Pee Small Volumes (10 mL) device
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 Small Volumes (10 mL) deviceDevice

    Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.

Study groups in NCT04530201
Study groupRoleWhat they receive
Sample collectionOtherWomen will self-collect two first-void urine samples at home, the day prior to colposcopy. During the colposcopy visit, the clinician will collect an additional cervical smear. Colposcopy and histology results (when available) will be used as reference test.
Receives: Device: Colli-Pee Small Volumes (10 mL) device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).

    Analytical test results:

    HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) concentrations [cycle threshold values] in first-void urine samples from all study participants.

    Clinical test accuracy:

    HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].

    Measured: Through study completion, an average of 1 year

  2. Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).

    Analytical test results:

    Methylation levels of a host cell gene marker panel (PreCursor-U+) reported in a methylation ratio [(2^-deltaCT *100) with CT being cycle threshold values] in first-void urine samples from all study participants.

    Clinical test accuracy:

    Methylation panel (PreCursor-U+) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. Human DNA (GAPDH)

    Human DNA (GAPDH) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).

    Measured: Through study completion, an average of 1 year

  2. Internal control DNA (IC DNA)

    Internal control DNA (IC DNA) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).

    Measured: Through study completion, an average of 1 year

  3. Human DNA (Beta-globin)

    Human DNA (Beta-globin) concentrations [cycle threshold values] in first-void urine samples from all study participants measured using the HPV-risk assay (Self-Screen BV).

    Measured: Through study completion, an average of 1 year

  4. Human DNA reference gene (ACTB)

    Human DNA reference gene (ACTB) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative methylation specific PCR (qMSP).

    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.

  1. First posted28 Aug 2020
  2. Study start20 Aug 2020
  3. Primary completion20 Oct 2021
  4. Study completion28 Feb 2022

Resources

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
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530201
Sponsor's protocol ID
BE3002020000101
Acronym
CASUS-WP4
Status last verified
Jun 2022
First submitted
24 Aug 2020
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Keer S, Teblick L, Donders G, Weyers S, Doyen J, Cornelis A, Van de Vijver K, Delbecque K, De Smet A, Van Damme P, Vorsters A. Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First-Void Urine Collector. J Med Virol. 2025 Feb;97(2):e70254. doi: 10.1002/jmv.70254.

    PubMed 39981930

  • Hendrickx JO, Van Keer S, Donders G, Weyers S, Doyen J, Beyers KCL, Rios-Cortes A, Meers N, Teblick L, Vankerckhoven VVJ. Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study. Arch Public Health. 2025 Feb 12;83(1):32. doi: 10.1186/s13690-024-01490-3.

    PubMed 39934916

Questions about this trial

What is this clinical trial studying?

A study testing Colli-Pee Small Volumes (10 mL) device in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Universiteit Antwerpen at 3 sites 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 4 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV). (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530201, which also lists 2 linked publications.

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 15 Jun 2022.

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