Dry Run of the ScreenUrSelf Trial

NCT05996796 | Completed

• 1 other identifier: B3002023000038
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is the Dry Run preceding the ScreenUrSelf trial.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HPV DNA using the Riatol qPCR HPV genotyping assay

  HPV DNA concentration \[copies/µl DNA\] in self-samples from all study participants.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay

  Through study completion, an average of 1 year

• Preferences

  Through study completion, an average of 1 year

Study Arms (4)

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.

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.

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.

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.

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: 30 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
• No history of total hysterectomy
• No (former) diagnosis of cervical or uterine cancer
• 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: DIAGNOSTIC
• 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: April 10, 2023
• Primary Completion: June 12, 2023
• Study Completion: June 15, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)