CASUS: Validation for Detection of Precursor Lesions (CASUS-WP4)

Universiteit Antwerpen

Status: Completed

Conditions: HPV-Related Cervical Carcinoma; Human Papilloma Virus; Urine; Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Device: Colli-Pee Small Volumes (10 mL) device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04530201

BE3002020000101

Details and patient eligibility

About

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).

Full 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).

Enrollment: 332 patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

332 participants in 1 patient group

Sample collection

Other group

Description:

Women will self-collect two first-void urine samples at home, the day prior to colposcopy. During the colposcopy visit, the clinician will collect an additional cervical smear. Colposcopy and histology results (when available) will be used as reference test.

Treatment:

Device: Colli-Pee Small Volumes (10 mL) device