NCT06598176 Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
| NCT ID | NCT06598176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Uterine Cervical Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-28 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Wiebren Tjalma, MD, PhD
PRINCIPAL INVESTIGATOR
Universiteit Antwerpen
Frequently Asked Questions
Who can join the NCT06598176 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 64 Years, studying Uterine Cervical Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06598176 currently recruiting?
Yes, NCT06598176 is actively recruiting participants. Contact the research team at alex.vorsters@uantwerpen.be for enrollment information.
Where is the NCT06598176 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06598176 clinical trial?
NCT06598176 is sponsored by Universiteit Antwerpen. The principal investigator is Wiebren Tjalma, MD, PhD at Universiteit Antwerpen. The trial plans to enroll 100 participants.