CASUS: Validation for Detection of Precursor Lesions
CASUS: Validation for Detection of Precursor Lesions
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 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).
Inclusion Criteria:

 -  Female

 -  25 years until 64 years old

 -  Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection
 and/or abnormal cervical squamous intraepithelial/glandular lesion.

 -  Gives informed consent to the research team at the clinical study site to contact
 his/her general practitioner and/or gynaecologist to access details of the
 participants HPV test results and cervical screening history.

 -  Is able to understand the information brochure/what the study is about.

 Exclusion Criteria:

 -  Women that underwent hysterectomy

 -  Pregnant women

 -  Treatment for cervical cancer in the last 6 months before participation in the study

 -  Participating in an 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.