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)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 64
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
RECRUITING
Edegem
Contact Information
Primary
Alex Vorsters, Ir, PhD
alex.vorsters@uantwerpen.be
032659130
Backup
Eef van den Borst, MSc
eef.vandenborst@uantwerpen.be
032652665
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2037-02-28
Participants
Target number of participants: 100
Treatments
Experimental: Sample collection
Women will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Antwerp
Leads: Universiteit Antwerpen