Clinical trial NCT04530201: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Urine
Keywords: Biomarker
First-void urine
Screening
Triage
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Novosanis NV
name: Self-screen B.V.
First posted: 2020-08-28
Enrollment: 332
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Through study completion, an average of 1 year
measure: Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Human DNA (GAPDH)
timeFrame: Through study completion, an average of 1 year
measure: Internal control DNA (IC DNA)
timeFrame: Through study completion, an average of 1 year
measure: Human DNA (Beta-globin)
timeFrame: Through study completion, an average of 1 year
measure: Human DNA reference gene (ACTB)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)
state: Oost-Vlaanderen
city: Tienen
country: Belgium
facility: Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen
state: Vlaams-Brabant
city: Liège
country: Belgium
facility: Gynécologie-obstétrique - CHU de Liège
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Alex Vorsters, Ir, PhD
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Severien Van Keer, PhD
role: STUDY_CHAIR
References: