Actively Recruiting
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Led by Universiteit Antwerpen · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
674 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 at the same time
- 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 HIV, Hepatitis B or Hepatitis C
- Patients who are alcoholic or drug abusers
- Patients with conditions or abnormalities that might affect study results or patient safety according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
Research Team
A
Alex Vorsters, Ir, PhD
CONTACT
E
Eef van den Borst, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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