Clinical trial NCT05996796: Dry Run of the ScreenUrSelf Trial
Official title: Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Keywords: Biomarker
First-void urine
Vaginal sample
Screening
Triage
Self-sampling
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: 38
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The proposed study is the Dry Run preceding the ScreenUrSelf trial.

Detailed description: The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening program. The goal of ScreenUrSelf 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). 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 practice within the organized cervical cancer screening program in Flanders).

The Dry Run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf trial. The primary outcome of the Dry Run is to check if the flow for data- and sample collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed necessary before start of the trial.

Eligibility criteria: Inclusion Criteria:

* Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:

  * Female
  * Residing in Flanders, Belgium
  * No history of total hysterectomy
  * No (former) diagnosis of cervical or uterine cancer
  * 30 - 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: HPV DNA using the Riatol qPCR HPV genotyping assay
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay
timeFrame: Through study completion, an average of 1 year
measure: Preferences
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: