The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.
Female
25 until 64 years old
Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)
Has not started any form of cancer treatment prior to study enrollment
Women that underwent hysterectomy
Pregnant women or 6 weeks post-partum
Treatment for cervical (pre)cancer in the last 6 months before participation in the study
Participating in another 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.
Single group
Colli-Pee 20mL device with UCM
DeviceWomen will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium).
Evalyn Brush
DeviceWomen will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.
Detection of (epi)genetic biomarkers for cervical cancer and precancer
A novel assay will be developed for the detection of the human papillomavirus (HPV) and epigenetic biomarkers to determine the presence of cervical (pre)cancer. Using histology outcomes as a reference test.
Comparison of the biomarkers detected in the different sample types.
The biomarkers detected in each of the sample types and their performance will be compared.
Demonstrate non-inferiority of the biomarker assay in self-samples compared to conventional cytology on pap smears.
Demonstrate non-inferiority of the developed biomarker assay in self-samples (index tests) compared to conventional cytology on pap smears (comparator test) for the detection of cervical (pre)cancer, using histology outcomes from tissue samples as reference test.
Determine the predictive value of the biomarker assay and the long-term risk of cervical (pre)cancer
Determine the developed biomarker assay's predictive value and long-term risk of cervical (pre)cancer after an initial test-outcome. Measuring the cumulative incidence of cervical (pre)cancer over time. Using histology outcomes from tissue samples ten years pre- and post-study enrolment as reference test outcomes.
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Universiteit Antwerpen
Lead sponsor
University Hospital, Antwerp
Collaborator
