Testing a self-sample molecular test for cervical cancer screening
Tests a self-collected sample screening method for cervical disease and HPV in women.
Plain-language title generated from the registry record
Registry title: Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Key facts
- Where
- Edegem, BelgiumSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 64 years old?
Source: NCT06598176, who can take part
Where in Belgium
- Universitair Ziekenhuis Antwerpen (Uza)Edegem, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universiteit Antwerpen
- Trial code
- NCT06598176
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Patient received blood transfusion two weeks before sample collection; Patients who are alcoholic or drug abusers; Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C; Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator; Women that underwent hysterectomy; Pregnant women or 6 weeks post-partum; Unable to give informed consent; Patient has severe anaemia; Blood sampling would compromise patients' overall health.