Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-64
SponsorUniversiteit Antwerpen

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Colli-Pee 20mL device with UCM
  • Evalyn Brush

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Universiteit Antwerpen

Lead sponsor

University Hospital, Antwerp

Collaborator