CASUS: Improved and Quality Assured Collection of First-void Urine

Not Applicable

Completed

• Conditions: Urine; Human Papilloma Virus; HPV-Related Cervical Carcinoma; Cervical Intraepithelial Neoplasia; Cervical Cancer
• Interventions: Device: Colli-Pee® (FV5000 and Small Volumes)

• Registration Number: NCT04480866
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).

Detailed Description

CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void urine, a next-generation first-void urine collection device is necessary, which includes internal process control, novel collector tubes for collection of smaller urine volumes, and integration of a non-toxic nucleic acid preservative.

Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard' Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The optimal urine volume needed for detection of host and viral biomarkers, as well as optimization of the nucleic acid preservative solution by introduction of a sample/extraction validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using different DNA extraction protocols.

Study Timeline

• Study Start: 2019-07-30
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-27
• Study First Submitted: 2020-06-02
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Female
• 18 years and older
• Women with a high-risk HPV positive test result within six months prior to study enrolment.
• Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
• Able to understand the information brochure/what the study is about.

Exclusion Criteria

• Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
• Participating in another interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First-void urine collection	Colli-Pee® (FV5000 and Small Volumes)	Women self-collect three first-void urine samples (random order) at home.

Primary Outcome Measures

Name	Time	Method
Human DNA (GAPDH)	Evaluation/testing when all samples are collected [1 year]	Comparison of human DNA (GAPDH) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Human DNA reference gene (ACTB)	Evaluation/testing when all samples are collected [1 year]	Comparison of human DNA reference gene (ACTB) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
Internal control DNA (IC DNA)	Evaluation/testing when all samples are collected [1 year]	Comparison of internal control DNA (IC DNA) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).

Secondary Outcome Measures

Name	Time	Method
Human DNA (Beta-globin)	Evaluation/testing when all samples are collected [1 year]	Comparison of human DNA (Beta-globin) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))	Evaluation/testing when all samples are collected [1 year]	Comparison of HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) positivity (+/-) and concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).

Trial Locations

Locations (1)

Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp; 🇧🇪 Wilrijk, Antwerpen, Belgium