Status:
RECRUITING
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Uterine Cervical Neoplasm
Uterine Cervical Dysplasia
Eligibility:
FEMALE
25-64 years
Phase:
NA
Brief 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...
Detailed Description
Currently, there is still 37% of the Flemish population eligible for cervical cancer screening that remains un(der)screened. Self-collected urine and vaginal samples that can be collected from home an...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2037
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06598176
Start Date
March 28 2024
End Date
February 28 2037
Last Update
September 19 2024
Active Locations (1)
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1
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, Belgium, 2650