Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervix Cancer
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 48000
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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 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.
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/histology/pathological result retrieved from the Belgian Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women who opted out of the screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot projects are not eligible. Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish organized cervical cancer screening program, which is coordinated by CvKO under governance of the Flemish government. The goal is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). Comparison: The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practise within the organized cervical cancer screening program in Flanders). Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women that participate in each intervention and in the control arms at 12 months after initiation of the intervention (the intervention being one of six study arms). Response in this project is defined as having a preventive cervical screen exam, either by a self-sample or by a physician-taken Pap smear, at 12 months after initiation of the intervention.
Investigators
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen
Eligibility Criteria
Inclusion Criteria
- •Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:
- •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)
Outcomes
Primary Outcomes
Response rate
Time Frame: 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
Secondary Outcomes
- Compliance(19 months (until 31/12/2024))
- Preference(Through study completion, an average of 1 year)
- Age-related differences in response rate(10 months (until 31/03/2024))
- Socio-economic status-related differences differences in response rate(10 months (until 31/03/2024))
- Clinical accuracy of HPV assay(Through study completion, an average of 1 year)
- Clinical accuracy of methylation assay(Through study completion, an average of 1 year)
- Cost-effectiveness(Through study completion, an average of 1 year)