CASUS: Validation for Detection of Precursor Lesions

Universiteit Antwerpen332 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

332

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (3)

Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)

Ghent, Oost-Vlaanderen, Belgium

Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen

Tienen, Vlaams-Brabant, Belgium

Gynécologie-obstétrique - CHU de Liège

Liège, Belgium

Outcomes

Primary Outcomes

HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).

Analytical test results: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) concentrations \[cycle threshold values\] in first-void urine samples from all study participants. Clinical test accuracy: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) test outcomes \[positive, negative\] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology \[Cervical Intraepithelial Neoplasia grade 0-3+\].