About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Colli-Pee 20mL device with UCM
- Evalyn Brush
Treatment groups
Sponsors and collaborators
Universiteit Antwerpen
Lead sponsor
University Hospital, Antwerp
Collaborator