Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)

What this Trial Is About

Researchers are exploring a new molecular screening and triage method for cervical cancer that can be used with self-collected samples. This approach aims to provide an easy, non-invasive way for women to screen for cervical cancer and related precancer conditions, especially targeting those who are under-screened. The study focuses on detecting biomarkers like human papillomavirus (HPV) and DNA methylation to identify women needing treatment. Participants will collect a first-void urine sample using the Colli-Pee device and a vaginal self-sample with the Evalyn Brush at home, one day before their hospital visit. During the hospital appointment, a clinician will collect a cervical smear and blood sample. If the participant undergoes surgery as part of their standard care, tissue samples collected will also be analyzed. The study compares biomarker results from these samples with standard cytology and histology tests. Throughout the study, participants provide multiple sample types for laboratory analysis before starting any cancer treatment. Researchers will measure the presence of genetic and epigenetic markers linked to cervical cancer over 48 months and assess how well self-sampling compares to conventional Pap smears. Follow-up will include evaluating the predictive value of these biomarkers and the long-term risk of cervical precancer or cancer, with assessments continuing up to one year after study completion.

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples