Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samp
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 re
| Condition(s) | Uterine Cervical Neoplasm, Uterine Cervical Dysplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 * Written informed consent must be obtained from patient * Is able to understand the information brochure and what the study is about Exclusion Criteria: * 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 |
| Ages | 25 Years to 64 Years |
| Sex | Female |
| Lead sponsor | Universiteit Antwerpen |
| Locations | Edegem, Antwerpen, Belgium |
| Start date | 2024-03-28 |
| NCT ID | NCT06598176 |
| Official listing | https://clinicaltrials.gov/study/NCT06598176 |