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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL. Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.
Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp
Wilrijk, Antwerpen, Belgium
Human DNA (GAPDH)
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).
Time frame: Evaluation/testing when all samples are collected [1 year]
Internal control DNA (IC DNA)
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).
Time frame: Evaluation/testing when all samples are collected [1 year]
Human DNA reference gene (ACTB)
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).
Time frame: Evaluation/testing when all samples are collected [1 year]
Human DNA (Beta-globin)
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).
Time frame: Evaluation/testing when all samples are collected [1 year]
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
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).
Time frame: Evaluation/testing when all samples are collected [1 year]
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