Clinical trial NCT05996783: Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
Official title: Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervix Cancer
Cervical Intraepithelial Neoplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Keywords: Biomarker
First-void urine
Vaginal sample
Screening
Triage
Self-sampling
Prevention
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Antwerp University Hospital (UZA)
name: Centre for Cancer Detection (CvKO)
name: Sciensano
First posted: 2023-08-18
Enrollment: 48000
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Response rate
timeFrame: 10 months (until 31/03/2024)
Secondary outcomes:
measure: Compliance
timeFrame: 19 months (until 31/12/2024)
measure: Preference
timeFrame: Through study completion, an average of 1 year
measure: Age-related differences in response rate
timeFrame: 10 months (until 31/03/2024)
measure: Socio-economic status-related differences differences in response rate
timeFrame: 10 months (until 31/03/2024)
measure: Clinical accuracy of HPV assay
timeFrame: Through study completion, an average of 1 year
measure: Clinical accuracy of methylation assay
timeFrame: Through study completion, an average of 1 year
measure: Cost-effectiveness
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universiteit Antwerpen
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: