Dry Run of the ScreenUrSelf Trial
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Antwerp
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Edegem, Antwerp, Belgium, 2650
- Universiteit Antwerpen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Opt-out first-void urine
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. |
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.
|
|
Experimental: Opt-in first-void urine
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. |
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.
|
|
Experimental: Opt-out vaginal self-sample
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. |
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.
|
|
Experimental: Opt-in vaginal self-sample
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV DNA using the Riatol qPCR HPV genotyping assay
Time Frame: Through study completion, an average of 1 year
|
HPV DNA concentration [copies/µl DNA] in self-samples from all study participants.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay
Time Frame: Through study completion, an average of 1 year
|
Human DNA concentration [copies/µl DNA] in self-samples from all study participants
|
Through study completion, an average of 1 year
|
|
Preferences
Time Frame: Through study completion, an average of 1 year
|
Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Van Damme, MD, PhD, Universiteit Antwerpen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Neoplasms, Squamous Cell
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Papilloma
Other Study ID Numbers
- B3002023000038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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