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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05996796
• Other study ID #: B3002023000038
• Status: Completed
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2023
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is the Dry Run preceding the ScreenUrSelf 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 15, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• Colli-Pee Small Volumes
Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
• Evalyn Brush
Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.

Locations

Country	Name	City	State
Belgium	Universiteit Antwerpen	Edegem	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Antwerp University Hospital (UZA), Centre for Cancer Detection (CvKO), Sciensano

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA using the Riatol qPCR HPV genotyping assay	HPV DNA concentration [copies/µl DNA] in self-samples from all study participants.	Through study completion, an average of 1 year
Secondary	Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay	Human DNA concentration [copies/µl DNA] in self-samples from all study participants	Through study completion, an average of 1 year
Secondary	Preferences	Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)	Through study completion, an average of 1 year