Cervical CancerNCT03542513
First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
An observational study of Cervical Cancer, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Colli-Pee and Qvintip
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Oct 2017to 25 Sep 2024
- Phase
- Observational
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: The cohort involves 100 women, diagnosed with histologically confirmed high grade CIN lesions requested for LLETZ treatment. Before this treatment an extra cervical sample is collected by the clinician. In addition, these women are asked to collect first-void urine samples with the Colli-Pee device, vaginal samples with the Qvintip device and to fill in a questionnaire.
Who may be able to join
- Female (18 years and older)
- Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions
- Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
- Not participating in another clinical study where a drug or biological is administered.
- Able to understand the information brochure/what the study is about.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University of Antwerp - Centre for the Evaluation of Vaccination
Wilrijk, Antwerp, 2610
About this study
Official title: Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).
Read the detailed description
In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling.
During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.
- Conditions
- Cervical Cancer
- Being tested
- Colli-Pee, Qvintip
- Keywords
- Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervical Intraepithelial Neoplasia, LLETZ
- 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-PeeDevice
Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).
QvintipDevice
Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).
What is being measured
The primary outcome is the main question the study is designed to answer.
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
Concordance hrHPV DNA status of self-collected first-void urine and vaginal samples from women treated for high-grade cervical lesions to that of physician sampled cervical specimens.
Measured: Within 6 months after study completion
Secondary outcomes (4)
hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.
Concordance hrHPV DNA status of self-collected first-void urine and vaginal fluid samples at home to self-collected samples at the hospital.
Measured: Within 6 months after study completion
Effect of treatment on HPV DNA presence.
Evaluate the effect of treatment on HPV DNA presence by the use of self-collected first-void urine and vaginal self-sampling for HPV DNA detection.
Measured: Within 6 months after study completion
Validate the performance of additional biomarkers.
Validate the performance of additional biomarkers (mRNA, genotyping, DNA methylation markers, viral load) for further staging of hrHPV infections.
Measured: Within 6 months after study completion
Preference of women for self-sampling methods.
Gather information about the preference of women for first-void urine sample collection compared vaginal self-sampling methods, and a clinician collected sample (smear).
Measured: Within 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start30 Oct 2017
- Primary completion12 Dec 2022
- Study completion25 Sep 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Pierre Van Damme, Principal investigator, Centre for the Evaluation of Vaccination
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542513
- Sponsor's protocol ID
- B300201732818
- Status last verified
- Jun 2025
- First submitted
- 18 May 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
- ClinicalTrials.gov ID
- NCT03542513
- Acronym / sponsor ID
- B300201732818
- Conditions
- Cervical Cancer
- Keywords
- Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervical Intraepithelial Neoplasia, LLETZ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 31 May 2018 (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 analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).
Detailed description
In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling.
During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The cohort involves 100 women, diagnosed with histologically confirmed high grade CIN lesions requested for LLETZ treatment. Before this treatment an extra cervical sample is collected by the clinician. In addition, these women are asked to collect first-void urine samples with the Colli-Pee device, vaginal samples with the Qvintip device and to fill in a questionnaire.
Key inclusion criteria (5 listed)
- Female (18 years and older)
- Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions
- Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
- Not participating in another clinical study where a drug or biological is administered.
- Able to understand the information brochure/what the study is about.
Key exclusion criteria (0 listed)
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-PeeUrine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium). | Device | – |
| QvintipVaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden). | Device | – |
Primary outcome
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
Time frame: Within 6 months after study completion
Concordance hrHPV DNA status of self-collected first-void urine and vaginal samples from women treated for high-grade cervical lesions to that of physician sampled cervical specimens.
4 secondary outcomes
hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.
Time frame: Within 6 months after study completion
Effect of treatment on HPV DNA presence.
Time frame: Within 6 months after study completion
Validate the performance of additional biomarkers.
Time frame: Within 6 months after study completion
Preference of women for self-sampling methods.
Time frame: Within 6 months after study completion
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 13 Jun 2025.
- 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 principal investigator
Centre for the Evaluation of Vaccination
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, 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 0 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 13 Jun 2025. 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?
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens. (time frame: Within 6 months after study completion). 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 Jun 2025.