Cervical Cancer, Cervical Intraepithelial Neoplasia, HPV-Related Cervical Carcinoma, Human Papilloma Virus, Urine
Conditions
Keywords
Biomarker, First-void urine, Screening, Triage
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).
Interventions
DEVICEColli-Pee Small Volumes (10 mL) device
Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.
Sponsors
Amsterdam UMC, location VUmc
Novosanis NV
Self-screen B.V.
Universiteit Antwerpen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Through study completion, an average of 1 year | 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 \[Cervical Intraepithelial Neoplasia grade 0-3+\]. |
| Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP). | Through study completion, an average of 1 year | Analytical test results: Methylation levels of a host cell gene marker panel (PreCursor-U+) reported in a methylation ratio \[(2\^-deltaCT \*100) with CT being cycle threshold values\] in first-void urine samples from all study participants. Clinical test accuracy: Methylation panel (PreCursor-U+) 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 \[Cervical Intraepithelial Neoplasia grade 0-3+\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human DNA (GAPDH) | Through study completion, an average of 1 year | Human DNA (GAPDH) concentrations \[cycle threshold values\] in first-void urine samples from all study participants measured by quantitative PCR (qPCR). |
| Internal control DNA (IC DNA) | Through study completion, an average of 1 year | Internal control DNA (IC DNA) concentrations \[cycle threshold values\] in first-void urine samples from all study participants measured by quantitative PCR (qPCR). |
| Human DNA (Beta-globin) | Through study completion, an average of 1 year | Human DNA (Beta-globin) concentrations \[cycle threshold values\] in first-void urine samples from all study participants measured using the HPV-risk assay (Self-Screen BV). |
| Human DNA reference gene (ACTB) | Through study completion, an average of 1 year | Human DNA reference gene (ACTB) concentrations \[cycle threshold values\] in first-void urine samples from all study participants measured by quantitative methylation specific PCR (qMSP). |
Countries
Belgium
Outcome results
None listed