Dry Run of the ScreenUrSelf Trial

Cervical Cancer Clinical 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

Status Completed

Clinical Trial Summary

The proposed study is the Dry Run preceding the ScreenUrSelf trial.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• HPV-Related Cervical Carcinoma
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

• NCT number: NCT05996796
• Study type: Interventional
• Source: Universiteit Antwerpen
• Status: Completed
• Phase: N/A
• Start date: April 10, 2023
• Completion date: June 15, 2023