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

Universiteit Antwerpen

Status: Active, not recruiting

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

Treatments: Device: Colli-Pee Small Volumes; Device: Evalyn Brush

Study type: Interventional

Funder types: Other

Identifiers

NCT05996783

B3002023000026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48,000 estimated patients

Sex: Female

Ages: 31 to 64 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48,000 participants in 6 patient groups

Control - no intervention

No Intervention group

Description:

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 group

Description:

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 group

Description:

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.

Treatment:

Device: Colli-Pee Small Volumes

Opt-in first-void urine

Experimental group

Description:

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.

Treatment:

Device: Colli-Pee Small Volumes

Opt-out vaginal self-sample

Experimental group

Description:

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.

Treatment:

Device: Evalyn Brush

Opt-in vaginal self-sample

Experimental group

Description:

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.

Treatment:

Device: Evalyn Brush