Colli-Pee Small Volumes: 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 Brush: 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 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 women), either on the woman or her physician's personal initiative, or by responding on the invitation letter.
Eligibility
Sex
FEMALE
Min age
31 Years
Max age
64 Years
Healthy volunteers
Accepted
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)
Primary outcome measure(s)
Response rate — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.