Status:
ACTIVE_NOT_RECRUITING
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
Antwerp University Hospital (UZA)
Centre for Cancer Detection (CvKO)
Conditions:
Cervix Cancer
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
31-64 years
Phase:
NA
Brief 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 n...
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/his...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
48000 Patients enrolled
Trial Details
Trial ID
NCT05996783
Start Date
May 25 2023
End Date
September 30 2026
Last Update
June 13 2025
Active Locations (1)
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1
Universiteit Antwerpen
Edegem, Antwerp, Belgium, 2650