Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Recruiting now · Not applicable
Conditions studied: Uterine Cervical Neoplasm, Uterine Cervical Dysplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06598176
- Run by
- Universiteit Antwerpen
- People needed
- 100
- Starts
- 2024-03-28
- Expected to finish
- 2037-02-28
- Last updated by the study team
- 2024-09-19
Who can join
Age: 25 and older, up to 64. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
- Unable to give informed consent
- Patient has severe anaemia
- Patient received blood transfusion two weeks before sample collection
- Blood sampling would compromise patients' overall health
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are alcoholic or drug abusers
- 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.
Where it is running
- Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerpen, Belgium (enrolling)
Full record on ClinicalTrials.gov
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