Cervical cancer screening based on first-void urine self-sampling to reach un(der)-screened women: ScreenUrSelf trial
Updated June 2025
Duration
1/10/2021-30/09/2026
Promotors and groups involved
ScreenUrSelf is a collaboration between the University of Antwerp (CEV: Pierre Van Damme (Principal Investigator), Severien Van Keer, Alex Vorsters; CHERMID: Philippe Beutels, Joke Bilcke), the Centre for Cancer Detection (Eliane Kellen, Patrick Martens), Sciensano (Marc Arbyn, Cindy Simoens), and Antwerp University Hospital (Elke Smits, Iris Verhaegen). This project was supported by a TBM-project (T004921N) and junior postdoctoral fellowship of the Research Foundation - Flanders (FWO), Belgium (Severien Van Keer; 1240220N).
A short project description
ScreenUrSelf aims to verify how effective the offer of urine or vaginal self-sampling is to reach women that are un(der)-screened for cervical cancer, compared to no intervention or standard practise in Flanders (Belgium) where women receive an invitation letter from the Centre for Cancer Detection to contact a physician for a Pap smear when they are overdue for screening. Would home-collected urine sampling be more preferred by un(der)-screened women than vaginal self-sampling, without negatively impacting compliance to follow-up?
To define which intervention is most (cost-)effective to reach un(der)-screened women for cervical cancer, a randomized controlled trial was embedded in the Flemish organized cervical screening program. 48,000 women (31-64 year) who were eligible for screening but were not screened for minimum two screening rounds were enrolled in May 2023. Women were randomized in six arms each comprising 8,000 women: two control (no intervention; recall letter) and four intervention arms. Interventions consist of receipt of a urine or vaginal self-sampling kit or receipt of a letter to order a urine or vaginal self-sampling kit.
The primary outcome is the response rate: proportion of women that participate in each study arm after initiation of the intervention. Response is defined as having a preventive cervical screen, by the self-sample or a Pap smear. Secondary study outcomes include percentage of screened positive women with follow-up or a positive screen test, positive predictive value of a positive screen test, detection rate of high-grade cervical neoplasia, preference and attitudes of women, age- and socioeconomic status-related differences in response rates, and cost-effectiveness outcomes.
With ScreenUrSelf, we want to provide answers on which self-sampling offer can reach more women that currently do not participate in organized cervical screening in Flanders, and is most cost-effective to impact on the burden of cervical cancer.
For more information
https://www.uantwerpen.be/en/projects/screenurself/