Cervical cancer screening using first-void urine self-sampling
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
This study is testing if women aged 31-64 in Flanders, Belgium, are more likely to get screened for cervical cancer when they can use self-sampling methods like first-void urine or vaginal sampling instead of just receiving invitation letters for Pap smears.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48000 (estimated) |
| Ages | 31 Years to 64 Years |
| Sex | Female |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT05996783 on ClinicalTrials.gov |
What this trial studies
The ScreenUrSelf trial aims to improve cervical cancer screening rates among women who have not participated in organized screening programs. This population-based study targets women aged 31-64 in Flanders, Belgium, who have not had any cervical screening results in the past six years. Participants will be offered two self-sampling methods—first-void urine and vaginal sampling—to collect samples for high-risk HPV testing. If HPV is detected, follow-up procedures will include standard cytology and methylation marker triage. The study compares these self-sampling methods against current practices of sending invitation letters for Pap smears.
Who should consider this trial
Good fit: Ideal candidates are women aged 31-64 residing in Flanders who have not participated in cervical cancer screening for at least six years.
Not a fit: Patients who are pregnant, have undergone total hysterectomy, or have a history of cervical or uterine cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase cervical cancer screening participation and early detection among under-screened women.
How similar studies have performed: Other studies have shown success with self-sampling methods for cervical cancer screening, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * 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) Exclusion Criteria: * 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)
Where this trial is running
Edegem, Antwerp
- Universiteit Antwerpen — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Pierre Van Damme, MD, PhD — Universiteit Antwerpen
- Study coordinator: Severien Van Keer, MSc, PhD
- Email: severien.vankeer@uantwerpen.be
- Phone: 03 265 41 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.