Cervix CancerScreenUrSelfNCT05996783
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
A study testing Colli-Pee Small Volumes and Evalyn Brush in people with Cervix Cancer and Cervical Intraepithelial Neoplasia, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and compliance to follow-up by offering a first-void urine self-sampling alternative to women who are currently not participating in the organized cervical cancer screening program (defined in this project as un(der)-screened… Read more about this study
- Who is it for?
- Ages 31 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus
- What is being tested?
- Colli-Pee Small Volumes and Evalyn Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48,000 participants
- Where
- 1 siteBelgium
- Study dates
- 25 May 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 31 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:
- Female
- Residing in Flanders, Belgium
- Not actively opted out of the organized cervical cancer screening program
- No history of total hysterectomy (data available since 2002)
- No (former) diagnosis of cervical or uterine cancer (data available as of 2008)
Show all 9Show fewer
- Not included in other CvKO pilot projects
- No cervical result registered in the cytohistopathological register of BCR and no information in the administrative data from health insurance companies (IMA) on PAP smears taken for at least the last 6 years (i.e., two screening rounds)
- 31-64 years old (birth year 1959-1992)
Who cannot join
- Being pregnant or 6 weeks postpartum (self-reported after receiving the study letter/package)
- Participation during menstruation or within the 3 following days is a contraindication
- Not able to understand the study materials and participation form (informed consent form)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and compliance to follow-up by offering a first-void urine self-sampling alternative to women who are currently not participating in the organized cervical cancer screening program (defined in this project as un(der)-screened women), either on the woman or her physician's personal initiative, or by responding on the invitation letter.
Read the detailed description
Patient: In this population-based study we target real un(der)-screened women, i.e., women (31-64y) eligible for the Flemish population-based cervical cancer screening program without any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women who opted out of the screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot projects are not eligible.
Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish organized cervical cancer screening program, which is coordinated by CvKO under governance of the Flemish government. The goal is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).
Comparison: The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practise within the organized cervical cancer screening program in Flanders).
Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women that participate in each intervention and in the control arms at 12 months after initiation of the intervention (the intervention being one of six study arms). Response in this project is defined as having a preventive cervical screen exam, either by a self-sample or by a physician-taken Pap smear, at 12 months after initiation of the intervention.
- Conditions
- Cervix Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
- Being tested
- Colli-Pee Small Volumes, Evalyn Brush
- Keywords
- Biomarker, First-void urine, Vaginal sample, Screening, Triage, Self-sampling, Prevention
- 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 VolumesDevice
Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
Evalyn BrushDevice
Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
| Study group | Role | What they receive |
|---|---|---|
| Control - no intervention | No intervention | This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician. No reminder letter will be sent. |
| Control - (recall) invitation letter | No intervention | This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening). A reminder letter will be sent after 5-6 months. |
| Opt-out first-void urine | Experimental | Women will receive a first-void urine self-sampling study package at home.
The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
A reminder letter will be sent after 5-6 months. Receives: Device: Colli-Pee Small Volumes |
| Opt-in first-void urine | Experimental | Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.
The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
A reminder letter will be sent after 5-6 months. Receives: Device: Colli-Pee Small Volumes |
| Opt-out vaginal self-sample | Experimental | Women will receive a vaginal self-sampling study package at home.
The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
A reminder letter will be sent after 5-6 months. Receives: Device: Evalyn Brush |
| Opt-in vaginal self-sample | Experimental | Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.
The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
A reminder letter will be sent after 5-6 months. Receives: Device: Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
*PP: participation in intervention arm measured by self-sample analyses only
**ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
Measured: 10 months (until 31/03/2024)
Secondary outcomes (7)
Compliance
- Compliance to a hrHPV positive result on a self-sample measured by standard of care follow-up, i.e., a Pap smear taken by a clinician.
- Compliance to an abnormal Pap smear measured by standard of care follow-up.
Measured: 19 months (until 31/12/2024)
Preference
Preference and attitudes of women between intervention arms (measured via a questionnaire)
Measured: Through study completion, an average of 1 year
Age-related differences in response rate
Age-related differences in response rates within and between different study arms
Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
*PP: participation in intervention arm measured by self-sample analyses only
**ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
Measured: 10 months (until 31/03/2024)
Socio-economic status-related differences differences in response rate
Socio-economic status-related differences in response rates within and between different study arms
Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
*PP: participation in intervention arm measured by self-sample analyses only
**ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
Measured: 10 months (until 31/03/2024)
Clinical accuracy of HPV assay
Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ of a hrHPV positive result on a self-sample in un(der)-screened women; absolute measures in each arm and ratios of measures between arms.
Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.
Measured: Through study completion, an average of 1 year
Clinical accuracy of methylation assay
Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate CIN2+ of a methylation-based reflex test (index test) to triage hrHPV positive self-sample in un(der)screened women, compared to reflex cytology on a Pap smear (comparator test); absolute measures in each arm and ratios of measures between arms.
Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.
Measured: Through study completion, an average of 1 year
Cost-effectiveness
- Differences in time needed per women to obtain a test result between study arms
- Differences in costs per women between the different study arms
- Differences in total cost between the different study arms
The above differences in time and costs will be combined to report cost-effectiveness.
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 posted18 Aug 2023
- Study start25 May 2023
- Primary completion31 Mar 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Antwerp University Hospital (UZA), Centre for Cancer Detection (CvKO), Sciensano
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Pierre Van Damme, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996783
- Sponsor's protocol ID
- B3002023000026
- Acronym
- ScreenUrSelf
- Status last verified
- Jun 2025
- First submitted
- 2 Aug 2023
- Last updated
- 13 Jun 2025
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
- ClinicalTrials.gov ID
- NCT05996783
- Acronym / sponsor ID
- ScreenUrSelf / B3002023000026
- Conditions
- Cervix Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
- Keywords
- Biomarker, First-void urine, Vaginal sample, Screening, Triage, Self-sampling, Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48,000 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Antwerp University Hospital (UZA), Centre for Cancer Detection (CvKO), Sciensano
- Study start
- 25 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Aug 2023 (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 ScreenUrSelf trial is to increase cervical cancer screening attendance and compliance to follow-up by offering a first-void urine self-sampling alternative to women who are currently not participating in the organized cervical cancer screening program (defined in this project as un(der)-screened women), either on the woman or her physician's personal initiative, or by responding on the invitation letter.
Detailed description
Patient: In this population-based study we target real un(der)-screened women, i.e., women (31-64y) eligible for the Flemish population-based cervical cancer screening program without any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women who opted out of the screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot projects are not eligible.
Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish organized cervical cancer screening program, which is coordinated by CvKO under governance of the Flemish government. The goal is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).
Comparison: The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practise within the organized cervical cancer screening program in Flanders).
Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women that participate in each intervention and in the control arms at 12 months after initiation of the intervention (the intervention being one of six study arms). Response in this project is defined as having a preventive cervical screen exam, either by a self-sample or by a physician-taken Pap smear, at 12 months after initiation of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control - no intervention | No intervention | –This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician. No reminder letter will be sent. |
| Control - (recall) invitation letter | No intervention | –This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening). A reminder letter will be sent after 5-6 months. |
| Opt-out first-void urine | Experimental | Device: Colli-Pee Small VolumesWomen will receive a first-void urine self-sampling study package at home. The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab. A reminder letter will be sent after 5-6 months. |
| Opt-in first-void urine | Experimental | Device: Colli-Pee Small VolumesWomen will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package. The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab. A reminder letter will be sent after 5-6 months. |
| Opt-out vaginal self-sample | Experimental | Device: Evalyn BrushWomen will receive a vaginal self-sampling study package at home. The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab. A reminder letter will be sent after 5-6 months. |
| Opt-in vaginal self-sample | Experimental | Device: Evalyn BrushWomen will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package. The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab. A reminder letter will be sent after 5-6 months. |
Who may qualify
- Ages
- 31 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:
- No cervical result registered in the cytohistopathological register of BCR and no information in the administrative data from health insurance companies (IMA) on PAP smears taken for at least the last 6 years (i.e., two screening rounds)
- 31-64 years old (birth year 1959-1992)
Key exclusion criteria (3 listed)
- Being pregnant or 6 weeks postpartum (self-reported after receiving the study letter/package)
- Participation during menstruation or within the 3 following days is a contraindication
- Not able to understand the study materials and participation form (informed consent form)
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 Small VolumesWomen will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope. | Device | Opt-in first-void urine, Opt-out first-void urine |
| Evalyn BrushWomen will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope. | Device | Opt-in vaginal self-sample, Opt-out vaginal self-sample |
Primary outcome
Response rate
Time frame: 10 months (until 31/03/2024)
Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention. *PP: participation in intervention arm measured by self-sample analyses only **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
7 secondary outcomes
Compliance
Time frame: 19 months (until 31/12/2024)
Preference
Time frame: Through study completion, an average of 1 year
Age-related differences in response rate
Time frame: 10 months (until 31/03/2024)
Socio-economic status-related differences differences in response rate
Time frame: 10 months (until 31/03/2024)
Clinical accuracy of HPV assay
Time frame: Through study completion, an average of 1 year
Clinical accuracy of methylation assay
Time frame: Through study completion, an average of 1 year
Cost-effectiveness
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Cervix Cancer
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Active, not recruiting
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
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
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 Small Volumes and Evalyn Brush in people with Cervix 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 9 inclusion and 3 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
Response rate (time frame: 10 months (until 31/03/2024)). 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.