Clinical trial · Interventional
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
NCT05996783CI-TRIAL-00090985ScreenUrSelfactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervix Cancer | — | UNRESOLVED | — |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colli-Pee Small Volumes | Device | — | UNRESOLVED |
| Evalyn Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Control - no intervention
- description
- 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.
- type
- NO_INTERVENTION
- label
- Control - (recall) invitation letter
- description
- 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.
- type
- EXPERIMENTAL
- label
- Opt-out first-void urine
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 31 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.