Spots Global Cancer Trial Database for CASUS: Validation for Detection of Precursor Lesions

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Trial Identification

Brief Title: CASUS: Validation for Detection of Precursor Lesions

Official Title: Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions

Study ID: NCT04530201

Conditions

Cervical Cancer

Cervical Intraepithelial Neoplasia

Human Papilloma Virus

HPV-Related Cervical Carcinoma

Urine

Interventions

Colli-Pee Small Volumes (10 mL) device

Study Description

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 4 (WP4): The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device, Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. The number of women in this cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA extracts of first-void samples after optimization of sample volume, internal process control, and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp, Belgium).