Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
Conditions
Keywords
Biomarker, First-void urine, Vaginal sample, Screening, Triage, Self-sampling
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.
Interventions
DEVICEColli-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.
DEVICEEvalyn 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.
Sponsors
Antwerp University Hospital (UZA)
Centre for Cancer Detection (CvKO)
Sciensano
Universiteit Antwerpen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Belgium
Outcome results
None listed