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Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial

NCT05996783 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48000

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Antwerp University Hospital (UZA)

    collaborator UNKNOWN

  • Centre for Cancer Detection (CvKO)

    collaborator UNKNOWN

  • Sciensano

    collaborator OTHER_GOV

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Pierre Van Damme, MD, PhD · Universiteit Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2024-03-31
Completion
2026-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996783 on ClinicalTrials.gov