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Trial Title:
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial
NCT ID:
NCT05996783
Condition:
Cervix Cancer
Cervical Intraepithelial Neoplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Conditions: Official terms:
Uterine Cervical Neoplasms
Papilloma
Uterine Cervical Dysplasia
Conditions: Keywords:
Biomarker
First-void urine
Vaginal sample
Screening
Triage
Self-sampling
Prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Colli-Pee Small Volumes
Description:
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.
Arm group label:
Opt-in first-void urine
Arm group label:
Opt-out first-void urine
Intervention type:
Device
Intervention name:
Evalyn Brush
Description:
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.
Arm group label:
Opt-in vaginal self-sample
Arm group label:
Opt-out vaginal self-sample
Summary:
The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance
and compliance to follow-up by offering a first-void urine self-sampling alternative to
women who are currently not participating in the organized cervical cancer screening
program (defined in this project as un(der)-screened women), either on the woman or her
physician's personal initiative, or by responding on the invitation letter.
Detailed description:
Patient: In this population-based study we target real un(der)-screened women, i.e.,
women (31-64y) eligible for the Flemish population-based cervical cancer screening
program without any cytology/histology/pathological result retrieved from the Belgian
Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women
who opted out of the screening program, who are pregnant (self-reported), underwent total
hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for
Cancer Detection (CvKO) pilot projects are not eligible.
Intervention: The proposed randomized controlled trial (RCT) will be embedded in the
Flemish organized cervical cancer screening program, which is coordinated by CvKO under
governance of the Flemish government. The goal 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).
Comparison: 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 practise within the organized cervical cancer screening program in Flanders).
Primary outcome: The primary outcome is the actual response rate, i.e., proportions of
women that participate in each intervention and in the control arms at 12 months after
initiation of the intervention (the intervention being one of six study arms). Response
in this project is defined as having a preventive cervical screen exam, either by a
self-sample or by a physician-taken Pap smear, at 12 months after initiation of the
intervention.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eligible for cervical cancer screening within the organized Population-based
Screening Program in Flanders:
- Female
- Residing in Flanders, Belgium
- Not actively opted out of the organized cervical cancer screening program
- No history of total hysterectomy (data available since 2002)
- No (former) diagnosis of cervical or uterine cancer (data available as of 2008)
- Not included in other CvKO pilot projects
- No cervical result registered in the cytohistopathological register of BCR and no
information in the administrative data from health insurance companies (IMA) on PAP
smears taken for at least the last 6 years (i.e., two screening rounds)
- 31-64 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)
Gender:
Female
Minimum age:
31 Years
Maximum age:
64 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Universiteit Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Severien Van Keer, MSc, PhD
Phone:
03 265 41 92
Phone ext:
+32
Email:
severien.vankeer@uantwerpen.be
Contact backup:
Last name:
Alex Vorsters, Ir, PhD
Phone:
03 265 91 30
Phone ext:
+32
Email:
alex.vorsters@uantwerpen.be
Start date:
May 25, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Universiteit Antwerpen
Agency class:
Other
Collaborator:
Agency:
Antwerp University Hospital (UZA)
Agency class:
Other
Collaborator:
Agency:
Centre for Cancer Detection (CvKO)
Agency class:
Other
Collaborator:
Agency:
Sciensano
Agency class:
Other
Source:
Universiteit Antwerpen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996783
