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

NCT05996783 | Active Not Recruiting

• 1 other identifier: B3002023000026
• Study Type: interventional
• Target: 48,000
• Locations: 1 country
• Sites: 1

Brief 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

Cervix Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma

Keywords

Biomarker; First-void urine; Vaginal sample; Screening; Triage; Self-sampling; Prevention

Outcome Measures

Primary Outcomes (1)

• Response rate

  Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention. \*PP: participation in intervention arm measured by self-sample analyses only \*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

  10 months (until 31/03/2024)

Secondary Outcomes (7)

• Compliance

  19 months (until 31/12/2024)

• Preference

  Through study completion, an average of 1 year

• Age-related differences in response rate

  10 months (until 31/03/2024)

• Socio-economic status-related differences differences in response rate

  10 months (until 31/03/2024)

• Clinical accuracy of HPV assay

  Through study completion, an average of 1 year

Study Arms (6)

Control - no intervention

NO INTERVENTION

This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician. No reminder letter will be sent.

Control - (recall) invitation letter

NO INTERVENTION

This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening). A reminder letter will be sent after 5-6 months.

Opt-out first-void urine

EXPERIMENTAL

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. A reminder letter will be sent after 5-6 months.

Device: Colli-Pee Small Volumes

Opt-in first-void urine

EXPERIMENTAL

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. A reminder letter will be sent after 5-6 months.

Device: Colli-Pee Small Volumes

Opt-out vaginal self-sample

EXPERIMENTAL

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. A reminder letter will be sent after 5-6 months.

Device: Evalyn Brush

Opt-in vaginal self-sample

EXPERIMENTAL

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. A reminder letter will be sent after 5-6 months.

Device: Evalyn Brush

Interventions

Colli-Pee Small Volumes DEVICE

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.

Opt-in first-void urine; Opt-out first-void urine

Evalyn Brush DEVICE

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.

Opt-in vaginal self-sample; Opt-out vaginal self-sample

Eligibility Criteria

• Age: 31 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• years old (birth year 1959-1992)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Antwerp University Hospital (UZA): collaborator
• Centre for Cancer Detection (CvKO): collaborator
• Sciensano: collaborator

Study Sites (1)

Universiteit Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Pierre Van Damme, MD, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 18, 2023
• Study Start: May 25, 2023
• Primary Completion: March 31, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)