Dry Run of the ScreenUrSelf Trial

Not Applicable

Completed

• Conditions: HPV-Related Cervical Carcinoma; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; Cervical Cancer
• Interventions: Device: Evalyn Brush; Device: Colli-Pee Small Volumes

• Registration Number: NCT05996796
• Lead Sponsor: Universiteit Antwerpen

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.

Study Timeline

• Study Start: 2023-04-10
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opt-in vaginal self-sample	Evalyn Brush	Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package. The study package will include an invitation letter/informed consent form, information brochure, vaginal 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.
Opt-out first-void urine	Colli-Pee Small Volumes	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.
Opt-in first-void urine	Colli-Pee Small Volumes	Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package. 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.
Opt-out vaginal self-sample	Evalyn Brush	Women will receive a vaginal self-sampling study package at home. The study package will include an invitation letter/informed consent form, information brochure, vaginal 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.

Primary Outcome Measures

Name	Time	Method
HPV DNA using the Riatol qPCR HPV genotyping assay	Through study completion, an average of 1 year	HPV DNA concentration \[copies/µl DNA\] in self-samples from all study participants.

Secondary Outcome Measures

Name	Time	Method
Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay	Through study completion, an average of 1 year	Human DNA concentration \[copies/µl DNA\] in self-samples from all study participants
Preferences	Through study completion, an average of 1 year	Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)

Trial Locations

Locations (1)

Universiteit Antwerpen; 🇧🇪 Edegem, Antwerp, Belgium